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KLARICID ADULT SACHET 250MG

Active substance(s): CLARITHROMYCIN

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MKP-00706-2017

PATIENT INFORMATION LEAFLET ON

Klaricid Adult Sachets 250mg/sachet
(Clarithromycin)

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or
your pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If you get any of the side effects, talk to your
doctor or pharmacist. This includes any possible
side effects not listed in the leaflet. See section 4.
What is in this leaflet:
1. What Klaricid Adult Sachets are and what they are
used for
2. What you need to know before taking Klaricid
Adult Sachets
3. How to take Klaricid Adult Sachets
4. Possible side effects
5. How to store Klaricid Adult Sachets
6. Contents of the pack and other information
1. What Klaricid Adult Sachets are and what they are used for
Each Klaricid Adult sachet contains 250 mg of the active ingredient clarithromycin. Klaricid belongs to a
group of medicines called macrolide antibiotics.
Antibiotics stop the growth of bacteria (bugs) that cause infections. Klaricid Adult Sachets are used to treat
infections such as:
1. Chest infections such as bronchitis and pneumonia
2. Throat and sinus infections
3. Skin and tissue infections
4. Helicobacter pylori infection associated with duodenal ulcer.
Klaricid Adult Sachets are indicated in adults and children 12 years and older.
2. What you need to know before taking Klaricid Adult Sachets
Do not take Klaricid Adult Sachets if you;
• know that you are allergic to clarithromycin, other macrolide antibiotics such as
erythromycin or azithromycin, or any of the other ingredients in the sachets.
• are taking medicines called ergot alkaloid tablets (e.g. ergotamine or dihydroergotamine)
or use ergotamine inhalers for migraine.
• are taking medicines called terfenadine or astemizole (widely taken for hay fever or
allergies) or cisapride (for stomach problems) or pimozide (for mental health problems)
as combining these drugs can sometimes cause serious disturbances in heart rhythm.
Consult your doctor for advice on alternative medicines.
• are taking other medicines which are known to cause serious disturbances in heart rhythm.
• are taking lovastatin or simvastatin (HMG-CoA reductase inhibitors, commonly known as statins, used to
lower levels of cholesterol (a type of fat) in the blood).
• are taking oral midazolam (a sedative)
• have abnormally low levels of potassium in your blood (hypokalaemia).
• have severe liver disease with kidney disease.
• or someone in your family has a history of heart rhythm disorders (ventricular cardia arrhythmia, including
torsades de pointes) or abnormality of electrocardiogram (ECG, electrical recording of the heart) called
“long QT syndrome”.
• are taking medicines called ticagrelor or ranolazine (for heart attack, chest pain or angina).
• are taking colchicine (usually taken for gout)
Warnings and precautions
Talk to your doctor or pharmacist before taking Klaricid Adult Sachets
• if you have heart problems (e.g. heart disease, heart failure, an unusually slow heart rate, or abnormally
low levels of magnesium in the blood (hypomagnesaemia))
• if you have any liver or kidney problems
• if you have, or are prone to, fungal infections (e.g. thrush)
• if you are pregnant or breast feeding
Other medicines and Klaricid Adult Sachets
You should not take Klaricid Adult Sachets if you are taking any of the medicines listed in the section above
“Do not take Klaricid Adult Sachets if you;”
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines as
your dose may need to be changed or you may need to have regular tests performed:
• digoxin, quinidine or disopyramide (for heart problems)
• warfarin, or any other anticoagulant (for blood thinning)
• carbamazepine, valproate, phenobarbital or phenytoin (for epilepsy)
• atorvastatin, rosuvastatin (HMG-CoA reductase inhibitors, commonly known as statins, and used to
lower levels of cholesterol (a type of fat) in the blood). Statins can cause rhabdomyolysis (a condition
which causes the breakdown of muscle tissue which can result in kidney damage) and signs of myopathy
(muscle pain or muscle weakness) should be monitored.
• nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (used to lower blood glucose levels)
• gliclazide or glimepiride (sulphonylureas used in the treatment of type II diabetes)
• theophylline (used in patients with breathing difficulties such as asthma)
• triazolam, alprazolam or intravenous or oromucosal midazolam (sedatives)
• cilostazol (for poor circulation)
• methylprednisolone (a corticosteroid)
• vinblastine (for treatment of cancer)
• ciclosporin, sirolimus and tacrolimus (immune suppressants)
• etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir (anti-viral drugs used in the
treatment of HIV)
• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used in the treatment of certain bacterial
infections)
• tolterodine (for overactive bladder)
• verapamil, amlodipine, diltiazem (for high blood pressure)
• sildenafil, vardenafil and tadalafil (for impotence in adult males or for use in pulmonary arterial
hypertension (high blood pressure in the blood vessels of the lung))
• St John’s Wort (a herbal product used to treat depression)
• quetiapine or other antipsychotic medicines.
• other macrolide medicines
• lincomycin and clindamycin (lincosamides – a type of antibiotic)
Please tell your doctor if you are taking oral contraceptive pills and diarrhoea or vomiting occurs, as you may
need to take extra contraceptive precautions such as using a condom.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist before taking Klaricid Adult Sachets as the safety of Klaricid Adult Sachets in
pregnancy and breast-feeding is not known.
Driving and Using Machines:
Klaricid Adult Sachets may make you feel dizzy or drowsy. If they affect you in this way do not drive, operate
machinery or do anything that requires you to be alert.
Klaricid Adult Sachets contain sucrose
This medicine contains sucrose, which is a type of sugar. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Klaricid Adult Sachets
Do not give these sachets to children under 12 years. Your doctor will prescribe another suitable medicine
for your child.
You may initially be given a pack containing two Klaricid Adult Sachets so that you can start your treatment
straight away. This sachet pack is not a full course of treatment. You should also receive a prescription for
the rest of the sachets that you need.
Mix the contents of the sachet with a small amount of water before taking to make the granules easier to
swallow.
For the treatment of chest infections, throat or sinus infections and skin and soft tissue infections:
The recommended dose of Klaricid Adult Sachets for adults and children over 12 years is 250 mg (1 sachet)
twice a day for 6 to 14 days e.g. one sachet in the morning and one sachet in the early evening. Your doctor
may increase the dose to 500 mg (2 sachets) twice daily in severe infections.
For the treatment of Helicobacter pylori infection associated with duodenal ulcers: There are a
number of effective treatment combinations available to treat Helicobacter pylori in which Klaricid Adult
Sachets are taken together with one or two other drugs. These combinations include the following and are
usually taken for 6 to 14 days:
a) Two Klaricid Adult Sachets taken twice a day together with amoxycillin, 1000mg taken twice a day plus
lansoprazole, 30mg twice a day.
b) Two Klaricid Adult Sachets taken twice a day together with metronidazole 400mg taken twice a day plus
lansoprazole, 30mg twice a day.
c) Two Klaricid Adult Sachets taken twice a day together with amoxycillin, 1000mg taken twice a day or
metronidazole 400mg taken twice a day plus omeprazole, 40mg a day.
d) Two Klaricid Adult Sachets taken twice a day together with amoxycillin, 1000mg taken twice a day plus
omeprazole, 20mg taken once a day.

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The treatment combination that you receive may differ slightly from the above. Your doctor will decide which
treatment combination is the most suitable for you. If you are unsure which medicine you should be taking or
how long you should be taking it for, please consult your doctor for advice.
If you take more Klaricid Adult Sachets than you should
If you accidentally take more Klaricid Adult Sachets in one day than your doctor has told you to, or if a
child accidentally swallows the contents of a sachet, contact your doctor or nearest hospital emergency
department immediately. An overdose of Klaricid Adult Sachets is likely to cause vomiting and stomach
pains.
If you forget to take Klaricid Adult Sachets
If you forget to take a Klaricid Adult Sachet, take one as soon as you remember. Do not take more sachets in
one day than your doctor has told you to.
If you stop taking Klaricid Adult Sachets
Do not stop taking Klaricid Adult Sachets, even if you feel better. It is important to take the sachets for as
long as the doctor has told you to, otherwise the problem might come back.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Klaricid Adult Sachets can cause side effects although not everybody
gets them.
If you suffer from any of the following at any time during your treatment STOP TAKING your
sachets and contact your doctor immediately:
• severe or prolonged diarrhoea, which may have blood or mucus in it. Diarrhoea may
occur over two months after treatment with clarithromycin, in which case you should still
contact your doctor.
• a rash, difficulty breathing, fainting or swelling of the face, tongue, lips, eyes and throat. This is a sign that
you may have developed an allergic reaction.
• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, tender abdomen or loss of appetite.
These are signs that your liver may have inflammation and not be working properly.
• severe skin reactions such as painful blistering of the skin, mouth, lips, eyes and genitals (symptoms of a
rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis)
• a red, scaly rash with bumps under the skin and blisters (symptoms of exanthematous pustulosis). The
frequency of this side effect is not known (cannot be estimated from the available data).
• rare allergic skin reactions which cause severe illness with ulceration of the mouth, lips and skin which
causes severe illness with rash, fever and inflammation of internal organs (DRESS).
• muscle pain or weakness known as rhabdomyolysis (a condition which causes the breakdown of muscle
tissue which can result in kidney damage).
Other side effects
Common side effects (may affect up to 1 to 10 people) include;
• difficulty sleeping
• changes in sense of taste
• headache
• widening of blood vessels
• stomach problems such as feeling sick, vomiting, stomach pain, indigestion, diarrhoea
• increased sweating
Uncommon side effects (may effect up to 1 in 100 people) include:
• high temperature
• swelling, redness or itchiness of the skin.
• oral or vaginal ‘thrush’ (a fungal infection)
• inflammation of the stomach and intestines
• decrease of the levels of blood platelets (blood platelets help stop bleeding)
• decrease in white blood cells (leukopenia)
• decrease in neutrophils (neutropenia)
• stiffness
• chills
• increase of eosinophils (white blood cells involved in immunity)
• exaggerated immune response to a foreign agent
• lack or loss of appetite
• anxiety, nervousness
• drowsiness, tiredness, dizziness or shaking
• involuntary muscle movements
• vertigo
• ringing in the ears or hearing loss
• chest pain or changes in heart rhythm such as palpitations or an irregular heartbeat
• asthma: lung disease associated with tightening of air passages, making breathing difficult
• nose bleed
• blood clot that causes sudden blockage in a lung artery (pulmonary embolism)
• inflammation of the lining of the gullet (oesophagus) and lining of the stomach
• anal pain
• bloating, constipation, wind, burping
• dry mouth
• situation where the bile (fluid made by the liver and stored in the gallbladder) cannot flow from the
gallbladder to the duodenum (cholestasis)
• inflammation of the skin characterized by the presence of the bullae which are filled with fluid, itchy and
painful rash
• muscle spasms, muscle pain or loss of muscle tissue. If you suffer from myasthenia gravis (a condition in
which the muscles become weak and tire easily), clarithromycin may worsen these symptoms.
• raised abnormal kidney and liver function blood test and raised blood tests
• feeling weak, tired and having no energy
Not known side effects (frequency cannot be estimated from the available data):
• inflammation of the colon
• bacterial infection of the outer layers of the skin
• reduction in the level of certain blood cells (which can make infections more likely or increase the risk of
bruising or bleeding)
• confusion, loss of bearings, hallucinations (seeing things), change in sense of reality or panicking,
depression, abnormal dreams or nightmares and mania (feeling of elation or over-excitement)
• convulsion (fits)
• paraesthesia, more commonly known as ‘pins and needles’
• loss of taste or smell or inability to smell properly
• type of heart rhythm disorder (Torsade de pointes, ventricular tachycardia)
• loss of blood (haemorrhage)
• inflammation of the pancreas
• discolouration of the tongue or teeth
• acne
• change in the levels of products produced by the kidney, inflammation of the kidney or an inability of the
kidney to function properly (you may notice tiredness, swelling or puffiness in the face, abdomen, thighs
or ankles or problems with urination)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By
reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Klaricid Adult Sachets
Keep this medicine out of sight and reach of children
Do not use these sachets after their use-by (exp) date that is printed on the box and indented on
the sachet.
Store these sachets below 30 °C in a cool, dry place.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Klaricid Adult Sachets contain
Each Klaricid Adult Sachets contains 250 mg of the active ingredient clarithromycin.
Other ingredients are : carbomers (carbopol 974P), hypromellose phthalate, castor oil, silicon dioxide,
maltodextrin, sucrose, titanium dioxide, Ultrasperse modified starch, orange bramble flavour, ammonium
glycyrrhizinate and acesulfame potassium.
What Klaricid Adult Sachets look like and contents of the pack
Klaricid 250 mg sachets are available in packs containing 2* or 14 sachets.
*The 2 sachet pack is a starter pack and is not a full course of treatment.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder: - Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, UK
Manufacturer: - AbbVie S.r.l., Via Pontina Km 52, 04011 Campoverde di Aprilia, Italy.
This leaflet was last revised in February 2018

MKP-00706-2017

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