Download Cloracef® Suspension Cefaclor

Cloracef® Suspension
Cefaclor
Read all of this leaflet carefully before you start taking this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
 If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Cloracef® is and what it is used for
2. Before you take Cloracef®
3. How to take Cloracef®
4. Possible side effects
5. How to store Cloracef®
6. Further information
1. What Cloracef® is and what it is used for
The name of your medicine is Cloracef®. It contains the active ingredient cefaclor
monohydrate.
Cloracef® is an antibiotic used to treat infections in different parts of the body caused
by bacteria.
Cloracef® belongs to a group of antibiotics called cephalosporins. These antibiotics
work by killing the bacteria that are causing your infection.
Cloracef® will not work against infections caused by viruses such as colds or the flu.
Cloracef® suspension is used to treat the following infections caused by bacteria that
can be killed by cefaclor:
 Bronchitis
 Infection of lung tissue (pneumonia)
 Bladder (cystitis) and kidney infections
 Throat infections including tonsillitis and pharyngitis
 Middle ear infections (otitis media)
 Skin and soft tissue (e.g. muscle) infections
 Infection of the sinuses (sinusitis).
Your doctor may have prescribed Cloracef® for another reason. Ask your doctor if you
have any questions about why Cloracef® has been prescribed for you.
This medicine is available only with a doctor’s prescription.
This medicine is not addictive.
2. Before you take Cloracef®
Do not take Cloracef®
Do not take Cloracef® if you have an allergy to:
 cefaclor, any other cephalosporins or any of the ingredients.
 any other similar medicines
Some of the symptoms of an allergic reaction may include:
 shortness of breath
 wheezing or difficulty breathing
 swelling of the face, lips or tongue or other parts of the body which may cause
difficulty in swallowing or breathing
 skin rash, itching or hives
Do not take this medicine if you have or have had any of the following medical
conditions:
 a serious allergic reaction to any penicillins. You may be more likely to have an
allergic reaction to Cloracef® if you are allergic to penicillin medicines.
Do not give Cloracef® to a premature baby or to a baby less than one month old. The
safety and effectiveness of Cloracef® have not been established in this age group.
Do not use Cloracef® if the packaging is torn or shows signs of tampering or if the
medicine does not look quite right.
Do not use Cloracef® if the expiry date printed on the pack has passed.
If you are not sure whether you should start taking Cloracef®, contact your doctor.
Take special care with Cloracef®
Tell your doctor if you have or have had any of the following medical conditions:
 type of allergic reaction to any penicillin medicines. You may have an increased
chance of being allergic to Cloracef® if you are allergic to penicillins.
 you have any allergies to any other medicines or any other substances, such as
foods, preservatives or dyes
 kidney problems
 stomach or bowel problems
 liver problems.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you take
Cloracef®.
If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if
it occurs several weeks after Cloracef® has been stopped. Diarrhoea may mean that you
have a serious condition affecting your bowel. You may need urgent medical care. Do
not take any diarrhoea medicine without first checking with your doctor.
If you get a sore white mouth or tongue while taking or soon after stopping Cloracef®,
tell your doctor. Also tell your doctor if you get vaginal itching or discharge. This may
mean you have a fungal infection called thrush. Sometimes the use of Cloracef® allows
fungi to grow and the above symptoms to occur. Cloracef® does not work against fungi.
If you have to test your urine for sugar while you are being given Cloracef®, make sure
your doctor knows which type of test you use. Cloracef® may affect the results of some
of these tests. If you have to have any blood tests tell your doctor you are taking
Cloracef® because it may affect the results of some blood tests.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking
Cloracef®.
Taking other medicines, herbal or dietary supplements
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines that you buy without a prescription.
Some medicines and Cloracef® may interfere with each other. These include:
 probenecid, a medicine used to treat gout
 oral anticoagulants.
These medicines may be affected by Cloracef®, or may affect how well it works. You
may need to take different amounts of your medicine, or you may need to take different
medicines. Your doctor will advise you.
Talk to your doctor about the need for an additional method of contraception while
taking Cloracef®.
Some antibiotics may decrease the effectiveness of some birth control pills.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking Cloracef®.
If you are about to start taking any new medicine, tell your doctor and pharmacist that
you are taking Cloracef®.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
If you become pregnant while you are taking Cloracef®, tell your doctor immediately.
Your doctor can discuss the risks and benefits involved.
Driving and using machines
Be careful driving or operating machinery until you know how Cloracef® affects you.
Cloracef® may cause drowsiness and dizziness in some people. Make sure you know
how you react to Cloracef® before you drive a car, operate machinery or do anything
else that may be dangerous if you are affected.
Children should be careful when riding bicycles or climbing trees.
Important information about some of the ingredients of Cloracef®
 Cloracef® suspension contains sucrose;
 If you have been told by your doctor that you have intolerance to some sugars,
contact your doctor before taking this medicinal product.
 Sucrose may be harmful to the teeth.
 Cloracef® suspension contains ponceau 4R red (E124) that may cause allergic
reactions.
3. How to take Cloracef®
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist for
help.
How much to take
Your doctor will tell you how much Cloracef® you need to take. This will depend on
the type of infection you have.
Adults
The usual dose of Cloracef® for adults and the elderly is 250 mg every 8 to 12 hours.
This dose may vary depending on your condition. For more severe infections the dose
may be doubled. The maximum daily dose is 4g.
Patients with a severe kidney disorder or patients receiving dialysis may need a different
dose.
Children
The dose for children varies according to the age of the child, their weight and the type
of infection.
For children, and babies over the age of one month, the usual total daily dosage is
20mg/kg (body weight). This total daily dose is usually divided into three and given
eight hours apart. For throat and middle ear infections the total daily dose can be
divided into two and given twelve hours apart. For more severe infections the dose may
be doubled. The maximum daily dose is 1g.
Your doctor and pharmacist will tell you the right amount to give your child.
For reconstitution of Cloracef® 125 and 250 suspensions:
Add 44 ml of purified water in two portions to the dry mixture in the bottle, shake well
after each addition.
For reconstitution of Cloracef® 375 suspension:
Add 43 ml of purified water in two portions to the dry mixture in the bottle, shake well
after each addition.
How to take it
Cloracef suspension is taken orally (by mouth).
When to take it
Cloracef® can be taken with or without food.
How long to take it
Continue taking this medicine for as long as your doctor tells you. Keep taking this
medicine for the full course of treatment, even if you begin to feel better after a few
days.
If you do not complete the full course prescribed by your doctor, the infection may not
clear completely or your symptoms may return.
If the symptoms of your infection do not improve within a few days, or if they become
worse, tell your doctor.
If you take more Cloracef® than you should
Go to accident and emergency at your nearest hospital, if you think that you or anyone
else may have taken too much Cloracef®. Do this even if there are no signs of
discomfort or poisoning. You may need urgent medical attention.
Symptoms of an overdose may include symptoms such as feeling sick in the stomach,
vomiting or diarrhoea.
If you forget to take Cloracef®
Take your dose as soon as you remember, and continue to take it as you would
normally.
If it is almost time for your next dose, skip the dose you missed and take your next dose
when you are meant to.
Do not take a double dose to make up for the dose that you missed. This may increase
the chance of you getting an unwanted side effect.
If you are not sure what to do ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you stop taking Cloracef®
Do not stop taking your Cloracef® because you are feeling better, unless advised by
your doctor.
If you do not complete the full course prescribed by your doctor, all of the bacteria
causing your infection may not be killed. These bacteria may continue to grow and
multiply so that your infection may not clear completely or it may return.
Do not use Cloracef® to treat any other complaints unless your doctor tells you to.
4. Possible side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are
taking Cloracef®.
All medicines can have side effects. Sometimes they are serious, most of the time they
are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
While taking Cloracef®
Tell your doctor if you notice any of the following and they worry you:
 oral thrush - white, furry, sore tongue and mouth
 vaginal thrush - sore and itchy vagina and/or discharge
 mild diarrhoea
 feeling sick, vomiting
 dizziness, drowsiness
 headache
 nervousness, hyperactivity
 inability to sleep.
These side effects are usually mild.
If any of the following happen, stop taking Cloracef® and tell your doctor immediately
or go to accident and emergency at your nearest hospital:
 severe abdominal cramps or stomach cramps
 watery and severe diarrhoea, which may also be bloody or contain mucus
 rash, itching, severe body rash with pinkish, itchy swellings of the skin (hives),
blistering or peeling of the skin
 signs of frequent infections such as fever, chills, sore throat or mouth ulcers
 pain or swelling of the joints
 yellowing of the skin or eyes
 shortness of breath, wheezing or difficulty in breathing
 swelling of the face, lips or tongue which may cause difficulty in swallowing or
breathing
 severe blisters and bleeding of the lips, eyes, mouth, nose and genitals
 unusual muscle stiffness causing poor control of movement
 confusion, hallucinations
 kidney pain, blood in the urine, passing more or less urine than is normal for you.
These are very serious side effects. You may need urgent medical attention or
hospitalization. Serious side effects are rare.
After taking Cloracef®
Tell your doctor immediately if you notice any of the following side effects, particularly
if they occur several weeks after stopping treatment with Cloracef®:
 severe abdominal cramps or stomach cramps
 watery and severe diarrhoea, which may also be bloody
 fever, in combination with one or both of the above.
These are rare but serious side effects. You may have a serious condition affecting your
bowel. Therefore, you may need urgent medical attention. However, this side effect is
rare.
Do not take any diarrhoea medicine without first checking with your doctor.
Other side effects not listed above may also occur in some patients. Tell your doctor if
you notice anything making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any of
them.
5. How to store Cloracef®
Keep out of the reach and sight of children.
Do not use Cloracef® after the expiry date which is stated on the carton. The expiry
date refers to the last day of that month.
Keep tightly closed. Protect from light. Do not store above 30°C. After reconstitution
store in the refrigerator between 2-8 °C. Discard unused portion after 14 days.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. Further information
What Cloracef® contains
Cloracef® 125 mg suspensions: Each 5 ml (teaspoonful) of reconstituted suspension
contains 125 mg of cefaclor (as cefaclor monohydrate).
Cloracef® 250 mg Forte suspensions: Each 5 ml (teaspoonful) of reconstituted
suspension contains 250 mg of cefaclor (as cefaclor monohydrate).
Cloracef® 375 mg suspensions: Each 5 ml (teaspoonful) of reconstituted suspension
contains 375 mg of cefaclor (as cefaclor monohydrate).
The other ingredients are: Xanthan gum, hypromellose, povidone, glycamil, citric acid
monohydrate, strawberry flavor, sodium laurilsulphate, simethicon, ponceau 4R red
(E124) and sucrose.
What Cloracef® looks like and contents of the pack
Cloracef® suspension bottles contain reddish pink granules with few white particles.
After reconstitution, the color of the suspension is reddish pink. The granules in each
bottle are sufficient to prepare 75 ml suspension.
Cloracef® 125 and 250 granules for suspension are filled in plastic bottles while
Cloracef® 375 is filled in amber glass bottles. Each bottle is enclosed in a carton along
with an insert and a measuring spoon.
Marketing Authorization Holder and Manufacturer
Dar Al Dawa Development & Investment Co. Ltd. (Na'ur – Jordan).
Tel. (+962 6) 57 27 132
Fax. (+962 6) 57 27 776
To report any side effects:
 Jordan

Contact marketing authorization holder
 Saudi Arabia

National Pharmacovigilance and Drug Safety Centre (NPC)
 Fax: + 966 112057662
 Call NPC at + 966 112038222, Exts: 2317-2356-2353-2354-2334-2340
 Toll free phone: 8002490000
 E-mail: [email protected]
 Website: www.sfda.gov.sa/npc
 United Arab Emirates

Pharmacovigilance Section-Drug Registration & Control Department
 Tel: + 971 26117391 or + 971 26117642
 Fax: + 971 26313742
 E-mail: [email protected]
 Website: www.moh.gov.ae
 Sudan

National Medicines and Poisons Board (NMPB)
 Fax: + 249 183522263
 E-mail: [email protected]
 Website : www.nmpb.gov.sd
 Other countries

Please contact the relevant competent authority.
12/2013
Comparison between the insert leaflets of
Cloracef® Suspension
NEW (12/2013) vs. OLD (03/05)
Indications
NEW (PIL)
1. What Cloracef® is and what it is used for
The name of your medicine is Cloracef®. It contains the
active ingredient cefaclor monohydrate.
Cloracef® is an antibiotic used to treat infections in
different parts of the body caused by bacteria.
Cloracef® belongs to a group of antibiotics called
cephalosporins. These antibiotics work by killing the
bacteria that are causing your infection.
Cloracef® will not work against infections caused by
viruses such as colds or the flu.
Cloracef® suspension is used to treat the following
infections caused by bacteria that can be killed by
cefaclor:
 Bronchitis
 Infection of lung tissue (pneumonia)
 Bladder (cystitis) and kidney infections
 Throat infections including tonsillitis and
pharyngitis
 Middle ear infections (otitis media)
 Skin and soft tissue (e.g. muscle) infections
 Infection of the sinuses (sinusitis).
OLD
INDICATIONS:
Cloracef is indicated in the treatment of infections caused by susceptible
Gram-negative and Gram-positive organisms: Otitis media, lower and
upper respiratory tract infections, intra-abdominal infections, skin and
soft tissue infections, urinary tract infections, gonorrhea, bone and joint
infections.
Contraindica
tions
Your doctor may have prescribed Cloracef® for another
reason. Ask your doctor if you have any questions about
why Cloracef® has been prescribed for you.
This medicine is available only with a doctor’s
prescription.
This medicine is not addictive.
1. Before you take Cloracef®
Do not take Cloracef®
Do not take Cloracef® if you have an allergy to:
 cefaclor, any other cephalosporins or any of the
ingredients.
 any other similar medicines
Some of the symptoms of an allergic reaction may
include:
 shortness of breath
 wheezing or difficulty breathing
 swelling of the face, lips or tongue or other parts
of the body which may cause difficulty in
swallowing or breathing
 skin rash, itching or hives
Do not take this medicine if you have or have had any
of the following medical conditions:
 a serious allergic reaction to any penicillins. You
CONTRAINDICATIONS:
Cloracef should not be administered to patients who have shown
hypersensitivity to cephalosporins. It is also contraindicated in patients
who have porphyria, since many drugs can induce acute porphyric crises.
may be more likely to have an allergic reaction to
Cloracef® if you are allergic to penicillin medicines.
Side effects
Do not give Cloracef® to a premature baby or to a baby
less than one month old. The safety and effectiveness
of Cloracef® have not been established in this age
group.
Do not use Cloracef® if the packaging is torn or shows
signs of tampering or if the medicine does not look
quite right.
Do not use Cloracef® if the expiry date printed on the
pack has passed.
If you are not sure whether you should start taking
Cloracef®, contact your doctor.
2. Possible side effects
Tell your doctor or pharmacist as soon as possible if
you do not feel well while you are taking Cloracef®.
All medicines can have side effects. Sometimes they
are serious, most of the time they are not. You may
need medical treatment if you get some of the side
effects.
Ask your doctor or pharmacist to answer any questions
you may have.
While taking Cloracef®
Tell your doctor if you notice any of the following and
they worry you:
SIDE EFFECTS:
As with other cephalosporins some patients may experience
gastrointestinal disturbances, nausea and vomiting, abdominal
discomfort, headache, allergic reactions, including rashes, pruritis,
urticarial, serum sickness-like reactions with rashes, fever , arthralgia and
anaphylaxis, disturbances in liver enzymes, transient hepatitis and
chotestatic jaundice. Other side effects reported include eosinophilia and
blood disorder, reversible interstitial nephritis, hype reactivity
nervousness, sleep disturbances, confusion hypertonia and dizziness.
 oral thrush - white, furry, sore tongue and mouth
 vaginal thrush - sore and itchy vagina and/or
discharge
 mild diarrhoea
 feeling sick, vomiting
 dizziness, drowsiness
 headache
 nervousness, hyperactivity
 inability to sleep.
These side effects are usually mild.
If any of the following happen, stop taking Cloracef®
and tell your doctor immediately or go to accident and
emergency at your nearest hospital:
 severe abdominal cramps or stomach cramps
 watery and severe diarrhoea, which may also be
bloody or contain mucus
 rash, itching, severe body rash with pinkish, itchy
swellings of the skin (hives), blistering or peeling of
the skin
 signs of frequent infections such as fever, chills,
sore throat or mouth ulcers
 pain or swelling of the joints
 yellowing of the skin or eyes
 shortness of breath, wheezing or difficulty in
breathing
 swelling of the face, lips or tongue which may
cause difficulty in swallowing or breathing
 severe blisters and bleeding of the lips, eyes,
mouth, nose and genitals
 unusual muscle stiffness causing poor control of
movement
 confusion, hallucinations
 kidney pain, blood in the urine, passing more or
less urine than is normal for you.
These are very serious side effects. You may need
urgent medical attention or hospitalization. Serious
side effects are rare.
After taking Cloracef®
Tell your doctor immediately if you notice any of the
following side effects, particularly if they occur several
weeks after stopping treatment with Cloracef®:
 severe abdominal cramps or stomach cramps
 watery and severe diarrhoea, which may also be
bloody
 fever, in combination with one or both of the
above.
These are rare but serious side effects. You may have a
serious condition affecting your bowel. Therefore, you
may need urgent medical attention. However, this side
effect is rare.
Do not take any diarrhoea medicine without first
checking with your doctor.
Other side effects not listed above may also occur in
some patients. Tell your doctor if you notice anything
making you feel unwell.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Warnings &
Precautions
Take special care with Cloracef®
Tell your doctor if you have or have had any of the
following medical conditions:
 type of allergic reaction to any penicillin
medicines. You may have an increased chance of
being allergic to Cloracef® if you are allergic to
penicillins.
 you have any allergies to any other medicines or
any other substances, such as foods, preservatives
or dyes
 kidney problems
 stomach or bowel problems
 liver problems.
Tell your doctor if you are pregnant or plan to become
pregnant or are breastfeeding.
Your doctor can discuss the risks and benefits involved.
If you have not told your doctor about any of the
above, tell them before you take Cloracef®.
If you get severe diarrhoea, tell your doctor or
pharmacist immediately. Do this even if it occurs
several weeks after Cloracef® has been stopped.
Diarrhoea may mean that you have a serious condition
affecting your bowel. You may need urgent medical
care. Do not take any diarrhoea medicine without first
PRECAUTIONS:
- Patients intolerant to penicillin may show cross sensitivity to
cephloaporins. Caution is recommended when cephalosporins are
administered to patients with a history of penicillin anaphylaxis.
-Pseudomembranous colitis has been reported with virtually all broad
spectrum antibiotics (including macrolides, semi synthetic penicillins, and
cephalosporins), therefore, it is important to consider its diagnosis in
patients who develop diarrhea in association with the use of antibiotics,
such colitis may range in severity from mild to life-threatening.
-Treatment with broad -spectrum antibiotics alters the normal flora of the
colon and may permit overgrowth of C. difficile. Toxins produce d by C.
difficile are the first cause of antibiotic- associated colitis. Mild-cases
respond positively to drug discontinuation. In moderate and severe cases,
Vancomycin is the drug of choice.
-Cephalosporins are excrete d in breast milk, usually in low
concentrations. Although problems in humans have not been
documented, risk-benefit ratio must be considered when cefaclor is given
to nursing women.
-Alcoholic beverages or other alcohol-containing preparations should be
avoided while receiving medicament.
In diabetics, false-positive reaction s with copper sulfate urine glucose
tests may occur.
checking with your doctor.
If you get a sore white mouth or tongue while taking or
soon after stopping Cloracef®, tell your doctor. Also tell
your doctor if you get vaginal itching or discharge. This
may mean you have a fungal infection called thrush.
Sometimes the use of Cloracef® allows fungi to grow
and the above symptoms to occur. Cloracef® does not
work against fungi.
If you have to test your urine for sugar while you are
being given Cloracef®, make sure your doctor knows
which type of test you use. Cloracef® may affect the
results of some of these tests. If you have to have any
blood tests tell your doctor you are taking Cloracef®
because it may affect the results of some blood tests.
Tell all the doctors, dentists and pharmacists who are
treating you that you are taking Cloracef®.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or plan to become
pregnant or are breastfeeding.
If you become pregnant while you are taking Cloracef®,
tell your doctor immediately.
Your doctor can discuss the risks and benefits involved.
Important information about some of the ingredients
of Cloracef®
 Cloracef® suspension contains sucrose;
 If you have been told by your doctor that you
have intolerance to some sugars, contact your
doctor before taking this medicinal product.

Sucrose may be harmful to the teeth.
 Cloracef® suspension contains ponceau 4R red
(E124) that may cause allergic reactions.
Drugs
interactions
Taking other medicines, herbal or dietary
supplements
Tell your doctor or pharmacist if you are taking any
other medicines, including any medicines that you buy
without a prescription.
Some medicines and Cloracef® may interfere with each
other. These include:
 probenecid, a medicine used to treat gout
 oral anticoagulants.
These medicines may be affected by Cloracef®, or may
affect how well it works. You may need to take
different amounts of your medicine, or you may need
to take different medicines. Your doctor will advise
you.
Talk to your doctor about the need for an additional
DRUG INTERACTIONS:
- Staphylococci exhibit cross resistance between Cloracef and methicillin
type antibiotics.
- Increased prothrombin time with or without clinical bleeding in patients
receiving Cloracef and coumarin concomitantly.
method of contraception while taking Cloracef®.
Some antibiotics may decrease the effectiveness of
some birth control pills.
Your doctor and pharmacist have more information on
medicines to be careful with or avoid while taking
Cloracef®.
If you are about to start taking any new medicine, tell
your doctor and pharmacist that you are taking
Cloracef®.
Dosage &
administrati
on
3. How to take Cloracef®
Follow all directions given to you by your doctor or
pharmacist carefully.
They may differ from the information contained in this
leaflet.
If you do not understand the instructions on the pack,
ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you how much Cloracef® you need
to take. This will depend on the type of infection you
have.
Adults
The usual dose of Cloracef® for adults and the elderly is
250 mg every 8 to 12 hours. This dose may vary
depending on your condition. For more severe
infections the dose may be doubled. The maximum
DOSAGE:
- The usual adult dose is 250 mg capsule every 8 hours. For more severe
infections such as pneumonia, dose may be doubled to 500 mg every 8
hours.
- The recommended dosage for children is 20 mg/kg /day in divided doses
every 8 hour s, for more serious infections such as otitis media, dose may
be doubled 10 40mg/kg/day in divided doses. Maximum dosage is
1gm/1day. In the treatment of B-hemolytic streptococcal infections,
Cloracef should be administered for at least 10 days.
For the treatment of pharyngitis and otitis media, the total daily dosage
maybe administered every 12 hours.
Cloracef dosage should be suitably reduced in patients with marked
impaired renal function.
daily dose is 4g.
Patients with a severe kidney disorder or patients
receiving dialysis may need a different dose.
Children
The dose for children varies according to the age of the
child, their weight and the type of infection.
For children, and babies over the age of one month,
the usual total daily dosage is 20mg/kg (body weight).
This total daily dose is usually divided into three and
given eight hours apart. For throat and middle ear
infections the total daily dose can be divided into two
and given twelve hours apart. For more severe
infections the dose may be doubled. The maximum
daily dose is 1g.
Your doctor and pharmacist will tell you the right
amount to give your child.
For reconstitution of Cloracef® 125 and 250
suspensions:
Add 44 ml of purified water in two portions to the dry
mixture in the bottle, shake well after each addition.
For reconstitution of Cloracef® 375 suspension:
Add 43 ml of purified water in two portions to the dry
mixture in the bottle, shake well after each addition.
How to take it
Cloracef suspension is taken orally (by mouth).
When to take it
Cloracef® can be taken with or without food.
How long to take it
Continue taking this medicine for as long as your
doctor tells you. Keep taking this medicine for the full
course of treatment, even if you begin to feel better
after a few days.
If you do not complete the full course prescribed by
your doctor, the infection may not clear completely or
your symptoms may return.
If the symptoms of your infection do not improve
within a few days, or if they become worse, tell your
doctor.
If you forget to take Cloracef®
Take your dose as soon as you remember, and
continue to take it as you would normally.
If it is almost time for your next dose, skip the dose you
missed and take your next dose when you are meant
to.
Do not take a double dose to make up for the dose that
you missed. This may increase the chance of you
getting an unwanted side effect.
If you are not sure what to do ask your doctor or
pharmacist.
If you have trouble remembering to take your
medicine, ask your pharmacist for some hints.
If you stop taking Cloracef®
Overdosage
Driving and
using
machines
Do not stop taking your Cloracef® because you are
feeling better, unless advised by your doctor.
If you do not complete the full course prescribed by
your doctor, all of the bacteria causing your infection
may not be killed. These bacteria may continue to grow
and multiply so that your infection may not clear
completely or it may return.
Do not use Cloracef® to treat any other complaints
unless your doctor tells you to.
If you take more Cloracef® than you should
Go to accident and emergency at your nearest hospital,
if you think that you or anyone else may have taken
too much Cloracef®. Do this even if there are no signs
of discomfort or poisoning. You may need urgent
medical attention.
Symptoms of an overdose may include symptoms such
as feeling sick in the stomach, vomiting or diarrhoea.
Driving and using machines
Be careful driving or operating machinery until you
know how Cloracef® affects you.
Cloracef® may cause drowsiness and dizziness in some
people. Make sure you know how you react to
Cloracef® before you drive a car, operate machinery or
do anything else that may be dangerous if you are
affected.
Children should be careful when riding bicycles or
climbing trees.
OVERDOSAGE:
The toxic symptoms following an overdose of cefaclor may include
nausea, vomiting, epigastric distress and diarrhea.
Absorption of the drug from gastrointestinal tract may be decreased by
giving activated charcoal, which in many cases is more effective than
emesis or gastric lavage. Repeated doses of charcoal over time may
accelerate the elimination of the drug that have been absorbed.
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Dar Al Dawa
Development & Investment Co.Ltd