Clarithromycin 125 mg/5 ml suspension – patient leaflet, side effects, dosage

1 What Clarithromycin is and what it is used for

Clarithromycin is an antibiotic which belongs to the group of macrolide antibiotics. It stops the growth of certain bacteria.

Clarithromycin is used in adults, adolescents and children (6 months to 12 years) to treat infections caused by bacteria which are sensitive to clarithromycin, for example:

• Throat and sinus infections
• Middle ear infections in children
• Chest infections, such as bronchitis and pneumonia
• Skin and soft‑tissue infections
• Gastric ulcers caused by the bacterium Helicobacter pylori

2 What you need to know before you take Clarithromycin

Do not take Clarithromycin

• if you are allergic to clarithromycin, other macrolide antibiotics (such as erythromycin or azithromycin) or any of the other ingredients of this medicine (listed in section 6).
• if you or someone in your family has a history of heart rhythm disorders (ventricular arrhythmia, including torsades de pointes) or abnormality of electro‑cardiogram (ECG, electrical recording of the heart) called “long QT syndrome”.
• if you suffer from severe liver failure and kidney problems at the same time.
• if you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia).

• if you are taking:

  • ticagrelor, ranolazine or ivabradine (for heart attack, chest pain or angina)
  • ergotamine, dihydroergotamine (medicines to treat migraine)
  • oral midazolam (a sedative)
  • cisapride and domperidone (medicines to treat stomach disorders)
  • pimozide (medicine to treat mental illnesses)
  • terfenadine or astemizole (hay fever, antiallergics)

  • lovastatin, simvastatin (HMG‑CoA reductase inhibitors, commonly known as statins,

    medicines to lower cholesterol)

  • lomitapide (lipid‑lowering medicine)
  • colchicine (medicine to treat gout)
  • other medicines which are known to cause serious disturbances in heart rhythm. Warnings and precautions

Talk to your doctor or pharmacist before taking Clarithromycin:

• if you have reduced liver or kidney function
• if you are allergic to lincomycin or clindamycin (antibiotics)
• if you suffer from myasthenia gravis, a rare disease which causes muscle weakness
• if you have diabetes

• if you have, or have had, heart problems (e.g. heart disease, heart failure, an unusual

  slow heart rate)

• if you have, or are prone to, fungal infections (e.g. thrush)

• if you are pregnant or breast‑feeding

• if you have used Clarithromycin before on several occasions or for a long time. If you develop severe or prolonged diarrhoea during your treatment or up to two months after taking Clarithromycin, inform your doctor immediately. Inflammation of the colon (Pseudomembranous colitis) has been reported with nearly all antibiotics including clarithromycin. Other medicines and Clarithromycin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your dose may need to be adjusted, or you may need to have regular tests performed. Clarithromycin must not be taken with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, some medicines for treating high cholesterol and medicines that are known to cause serious disturbances in heart rhythm (see section “Do not take Clarithromycin”).

Certain other medicines may affect the effectiveness of Clarithromycin or vice‑versa. Such medicines include:

• Ibrutinib (medicine for chronic lymphocytic leukaemia)
• Alprazolam, triazolam or intravenous or buccal (oromucosal) midazolam (sedatives)
• Digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (heart medicines)
• Theophylline (antiasthmatic)
• Warfarin or any other anticoagulant e.g. dabigatran, rivaroxaban, apixaban, edoxaban (used to thin your blood)
• Atorvastatin, rosuvastatin (used to lower cholesterol levels). 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.
• Ciclosporin, sirolimus, tacrolimus (immunosuppressants)
• Carbamazepine, phenytoin, valproate or phenobarbitone (medicines to treat epilepsy)
• Cilostazol (used to improve circulation in the legs)
• Methadone (used in the treatment of opioid addiction)
• Insulin and other medicines for the treatment of diabetes (such as nateglinide, pioglitazone, rosiglitazone or repaglinide)
• Gliclazide or glimepiride (sulphonylureas used in the treatment of type II diabetes)
• Omeprazole (gastric medicine)

• Sildenafil, tadalafil, vardenafil (medicines to treat erectile dysfunction or for use in pulmonary arterial hypertension (high blood pressure in the blood vessels of the lung))

  • Tolterodine (to treat overactive bladder syndrome)
  • Vinblastine (medicine for cancer therapy)
  • Quetiapine or other antipsychotic medicines
  • Medicines with the risk to affect hearing, especially aminoglycosides, such as gentamicin or neomycin (group of antibiotics)
  • Atazanavir, saquinavir, efavirenz, etravirine, nevirapine (medicines to treat HIV)
  • Ritonavir (anti‑viral medicine used in the treatment of HIV)
  • Zidovudine (medicine to treat HIV). Leave a 4 hour interval between taking Clarithromycin and zidovudine.
  • Itraconazole, fluconazole (medicine to treat fungal infections)
  • Rifampicin, rifabutin, rifapentine (antibiotics)
  • Lincomycin and clindamycin (lincosamides – a type of antibiotic)
  • Other macrolide antibiotics (such as erythromycin or azithromycin)
  • St John’s Wort (a herbal product used to treat depression)
  • Hydroxychloroquine or chloroquine (used to treat conditions including rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines at the same time as clarithromycin may increase the chance of getting abnormal heart rhythms and other serious side effects that affect your heart.
  • Corticosteroids (e.g. methylprednisolone), given by mouth, by injection or inhaled (used to help suppress the body’s immune system - this is useful in treating a wide range of conditions) 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 for advice before taking this medicine.

The safety of Clarithromycin suspension in pregnancy and breast‑feeding is not known. Driving and using machines

Clarithromycin has generally no effect on the ability to drive or use machines but may cause side effects, such as drowsiness, dizziness, confusion and disorientation. If you feel affected you should not drive, operate machinery or take part in activities where you may put yourself or others at risk. Visual impairment and blurred vision may affect your ability to drive or operate machinery. Clarithromycin contains sucrose and sodium

This medicine contains 2.4 g sucrose per 5 ml ready‑for‑use suspension. This should be taken into account in patients with diabetes mellitus.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per 5 ml suspension, that is to say essentially ‘sodium-free’.

3 How to take Clarithromycin

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The dispensing label will tell you how much of this medicine you should take and how often you should take it. Please read it carefully. The dose your doctor prescribes depends on the type of infection and how bad the infection is. It also depends on how well your kidneys are working. Your doctor will explain this to you.

Adults and adolescents (12 years and older)

The recommended dose is 10 ml twice a day.

For severe infections or gastric ulcers caused by Helicobacter pylori the recommended dose is 20 ml twice a day.

Patients with kidney problems:

Depending on your kidney function, your doctor may need to prescribe a lower dose than the normal dose.

Children 6 months to 12 years

The daily amount is worked out according to the weight of the child.

The following table provides a guide to recommended doses:

Children who weigh less than 8 kg should be given a dose of 0.3 ml/kg twice a day. Doctors may sometimes prescribe higher or lower doses than these.

Duration of treatment

Your doctor will tell you how long Clarithromycin should be used, normally between 5 and 14 days. Do not stop treatment on your own decision, e.g. because you or your child feel better. If the use is stopped too early, the infection may return.

Method of use

Usually this medicine is given twice a day, once in the morning and again in the early evening. You may take this medicine with or without food.

This medicine can cause a bitter aftertaste when remaining in the mouth. This can be avoided by eating or drinking something immediately after the intake of the suspension. How to measure the dose

A 5 ml syringe marked at 2.5, 3.75 and 5 ml is provided with this medicine. It comes with an adaptor which fits onto the bottle. To measure the medicine:

• Shake the bottle

The following information is intended for healthcare professionals only:

For the preparation of the suspension fill the bottle with the following amount of water

• For 40 ml bottle add 23.6 ml of water

• For 50 ml bottle add 29.5 ml of water

  • For 60 ml bottle add 35.4 ml of water
  • For 70 ml bottle add 41.3 ml of water
  • For 80 ml bottle add 47.2 ml of water
  • For 100 ml bottle add 59.0 ml of water
  • For 120 ml bottle add 70.8 ml of water
• Put the adaptor into the mouth of the bottle
• Put the end of the syringe into the adaptor
• Turn the bottle upside‑down
• Pull the plunger to measure the dose you need
• Turn the bottle upright, remove the syringe, leave the adaptor on the bottle and close the bottle Always remember to shake the bottle before measuring out each dose. Giving the medicine using the syringe
• Make sure the child is supported in an upright position.
• Put the tip of the syringe carefully into the child’s mouth. Point the tip of the syringe towards the inside of the cheek.
• Slowly push down the plunger of the syringe: Do not squirt it out quickly.
• Allow the child time to swallow the medicine.

Alternatively, empty the measured dose from the pipette onto a spoon for your child to take the medicine from.

Store the syringe in a hygienic place with the medicine.

How to prepare this medicine

A doctor or pharmacist will prepare this medicine for you. To open the medicine bottle, you need to press the childproof top down and then turn it.

If you need to prepare this medicine yourself, you should fill the bottle with cold water to just under the measurement line marked on the bottle. Shake it well as soon as you have done that. Then put more water in right up to the measurement line marked on the bottle and shake it again. You only need to prepare the suspension once, at the beginning of your course. If you take more Clarithromycin than you should

If you have taken too much of this medicine, contact your doctor or nearest hospital as soon as possible. Symptoms of overdose may be vomiting and stomach pains.

If you forget to take Clarithromycin

If you forget to take Clarithromycin, continue your treatment following the normal dose recommended by your doctor. Do not take a double dose to make up for a forgotten dose. If you stop taking Clarithromycin

It is important that you take your medicine in accordance with the doctor’s instructions. Do not suddenly stop taking Clarithromycin without discussing it first with your doctor, even if you feel better. Otherwise symptoms may return.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects

If any of the following happens at any time during your treatment, stop taking this medicine and tell your doctor immediately or go to the nearest hospital:

Uncommon serious side effects (may affect up to 1 in 100 people)

• allergic reactions such as sudden difficulty in breathing, speaking and swallowing, swelling of the lips, tongue, eyes, face and neck, extreme dizziness or collapse, itchy, raised skin rash
• irregular heartbeat (change in the electrical activity of the heart)
• inflammation of the skin characterized by the presence of the bullae which are filled with fluid, itchy and painful rash (dermatitis bullous)

Serious side effects with unknown frequency (frequency cannot be estimated from the available data)

• fever, sore throat, more frequent infections, caused by a serious shortage of white blood cells (agranulocytosis)
• rash, fever, blood alterations (which may be a sign of severe hypersensitivity syndrome affecting main organs, called DRESS)
• yellowing of the skin and eyes (jaundice), nausea, skin irritation, loss of appetite, dark urine, pale stools, tender abdomen, abnormal liver blood test results. These are signs that your liver may have inflammation and not be working properly.
• diarrhoea that is serious, lasts a long time or has blood or mucus in it, with stomach pain or fever. This can be a sign of a serious bowel inflammation. Your doctor may discontinue the treatment. Do not take medicines that reduce bowel movements. Diarrhoea may occur over two months after treatment with clarithromycin, in which case you should still contact your doctor.
• severe pain in the abdomen and back. caused by pancreas inflammation
• high or low urine output, drowsiness, confusion, and nausea caused by kidney inflammation
• severe skin reactions such as painful blistering of the skin, mouth, lips, eyes or genital organs (symptoms of a rare allergic reaction called Stevens‑Johnson syndrome/toxic epidermal necrolysis)
• muscle pain or weakness known as rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage)
• a red, scaly rash with bumps under the skin and blisters (acute generalised exanthematous pustulosis)

Other possible side effects

Common (may affect up to 1 in 10 people)

• headache
• changes in the senses of taste (for example metallic or bitter taste)
• abdominal pain, feeling or being sick, diarrhoea, indigestion
• difficulty sleeping
• abnormal liver function test results
• rash
• excessive sweating
• widening of blood vessels

Uncommon (may affect up to 1 in 100 people)

• fever
• low levels of white blood cells (leukopenia, neutropenia)
• inflammation of the stomach and intestines
• increased number of eosinophils (white blood cells involved in immunity)
• increased number of platelets (thrombocythaemia)
• involuntary muscle movements
• stiffness
• chills
• increase of liver enzymes in the blood
• yeast infections (candidiasis)
• infections, for example of the vagina
• loss or reduction of appetite
• generally feeling unwell, weakness, tiredness
• anxiety, nervousness
• drowsiness, dizziness, somnolence, shaking, fainting
• spinning sensation (vertigo)
• impaired hearing, ringing in the ears (tinnitus)
• chest pain or changes in heart rhythm such as palpitations (feeling your heartbeat), QT prolongation or an irregular heartbeat
• inflammation of the gullet lining (oesophagus) and stomach lining, constipation, wind, dry mouth, belching, bloating
• itching, hives, red raised rash
• muscle spasms, muscle pain or loss of muscle tissue. If you or your child suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily), Clarithromycin may worsen these symptoms
• anal pain
• inflammation of the mouth and tongue
• inflammation of the liver (hepatitis)

• situation where the bile (fluid made by the liver and stored in the gallbladder) cannot flow from the gallbladder to the duodenum (cholestasis)

  • 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)
  • raised abnormal kidney and liver function blood test and raised blood tests Frequency not known (frequency cannot be estimated from the available data)
  • discolouration of the teeth and tongue
  • yellowing of your skin or whites of your eyes (jaundice)
  • certain bacterial infections of the skin and underlying tissues
  • disturbed sense of smell, loss of sense of smell or taste
  • deafness
  • acne
  • pain and weakness in muscles
  • abnormal urine colour
  • abnormal dreams or nightmares, loss of bearings, confusion, disorientation, hallucinations (seeing, feeling or hearing things that are not there), loss of contact with reality, a feeling of loss of identity, mania (feeling of elation or over‑excitement), depression
  • type of heart rhythm disorder (torsade de pointes, ventricular tachycardia, ventricular fibrillation)
  • convulsions (fits), tingling and numbness of the skin
  • bleeding (hemorrhage)
  • abnormal blood test results ‑ prolonged blood clotting time
  • unusual bruising or bleeding caused by low blood platelets (thrombocytopenia)
  • problems with your eye sight (blurred vision, vision impairment)

Clarithromycin may also affect some laboratory tests. If you have to go to hospital or doctors for a blood test it is important that you tell the doctor or nurse that you are taking Clarithromycin. 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 (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 Clarithromycin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.

Do not store above 25 °C.

After reconstitution: Do not store above 25 °C.

The suspension must be used within 14 days after preparation.

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 Clarithromycin contains

‑ The active substance is clarithromycin. 5 ml of reconstituted oral suspension contains 125 mg clarithromycin.

‑ The other ingredients are: poloxamer 188, povidone K30, hypromellose, macrogol 6000, titanium dioxide (E 171), methacrylic acid – ethyl acrylate copolymer (1:1), triethyl citrate, glycerol monostearate, polysorbate 80, sucrose, maltodextrin, potassium sorbate, colloidal anhydrous silica, xanthan gum, fruit punch flavouring (natural and artificial flavouring substances including maltodextrin, modified starch, sodium and maltol). What Clarithromycin looks like and contents of the pack

White to beige granules in 60 ml, 120 ml or 240 ml HDPE bottles with child resistant PP‑screw closures (press+turn) with guarantee ring and an oral PE/PP‑measuring syringe (5 ml) with filling marks at 2.5 ml, 3.75 ml and 5.0 ml and/or a PP‑measuring spoon with filling marks at 1.25 ml, 2.5 ml and 5.0 ml.

Pack sizes:

1 bottle contains 27.3 g granules for oral suspension for 40 ml ready‑for‑use suspension (required water amount: 23.6 ml) or

34.1 g granules for oral suspension for 50 ml ready‑for‑use suspension (required water amount: 29.5 ml) or

41.0 g granules for oral suspension for 60 ml ready‑for‑use suspension (required water amount: 35.4 ml) or

47.8 g granules for oral suspension for 70 ml ready‑for‑use suspension (required water amount: 41.3 ml) or

54.6 g granules for oral suspension for 80 ml ready‑for‑use suspension (required water amount: 47.2 ml) or

68.3 g granules for oral suspension for 100 ml ready‑for‑use suspension (required water amount: 59.0 ml) or

81.9 g granules for oral suspension for 120 ml ready‑for‑use suspension (required water amount: 70.8 ml).

Double pack of 2 x 60 ml ready‑for‑use suspension: 2 x 41.0 g granules for oral suspension each for 2 x 60 ml ready‑for‑use suspension each (required water amount: 2 x 35.4 ml each) 1, 2, 5, 10, 20, 30, 40, 50, 100 bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Ltd

Park View, Riverside Way

Watchmoor Park

Camberley, Surrey

GU15 3YL

United Kingdom

Manufacturer:

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

OR

Novartis Pharmaceuticals S.R.L.

Livenzeni Street no 7A

Targu Mures

RO – 540472

Romania

OR

Salutas Pharma GmbH

Otto‑von‑Guericke‑Allee 1

39179 Barleben

Germany

This leaflet was last revised in 07/2026.

Shake the bottle well as soon as you have filled it with water. After reconstitution with water the medicinal product results in a white to beige suspension.

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