KLARICID ADULT SACHET 250 MG - patient leaflet, side effects, dosage

Patient leaflet - KLARICID ADULT SACHET 250 MG

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 or domperidone (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)
are taking a medicine containing lomitapide
have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia).
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)
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)
ibrutinib (for cancer treatment)
warfarin, or any other anticoagulant e.g. dabigatran, rivaroxaban, apixaban (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)
methadone (used in the treatment of opioid addiction)
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.

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d) Two Klaricid Adult Sachets taken twice a day together with amoxycillin, 1000mg taken twice a day plus omeprazole, 20mg taken once a day.

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: 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, hypromellose phthalate, castor oil (virgin), silicon dioxide, titanium dioxide, sucrose, maltodextrin, ammonium glycyrrhizinate, orange bramble flavour, starch, modified 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.

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