Clarithromycin 500 mg Powder for concentrate for Solution for Infusion – patient leaflet, side effects, dosage

1. What Clarithromycin Infusion is and what it is used for

Clarithromycin Infusion contains the active ingredient clarithromycin. Clarithromycin Infusion belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) that cause infections.

Clarithromycin Infusion is used whenever an intravenous (injection into the vein) antibiotic is required to treat severe infections or, alternatively, if a patient cannot swallow Clarithromycin tablets.

It is used to treat infections such as:

• Chest infections such as bronchitis and pneumonia
• Throat and sinus infections
• Skin and soft tissue infections

Clarithromycin Infusion is indicated in adults and children aged 12 years and older.

2. What you need to know before you are given Clarithromycin Infusion

You should not be given Clarithromycin Infusion 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).
• 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 disorders) or pimozide (for mental health problems) or ivabradine (for angina or heart failure) 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 (hypokalemia or hypomagnesaemia).
• have severe liver disease as well as kidney disease.
• or someone in your family has a history of heart rhythm disorders (ventricular cardiac 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, pharmacist or nurse before treatment with Clarithromycin Infusion

• 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.

Children

Clarithromycin Infusion is not suitable for use in children under 12 years of age.

Other medicines and Clarithromycin Infusion

You should not be given Clarithromycin Infusion

Package leaflet: Information for the user

if you are taking any of the medicines listed in the section above “You should not be given Clarithromycin Infusion if you”.

Tell your doctor or nurse if you are taking, have recently taken or might take any of the following medicines as your dose may need to be changed or you may need to have regular tests performed: • digoxin, disopyramide or quinidine (for heart problems).

• ibrutinib (for cancer treatment).
• warfarin, or any other anticoagulant e.g. dabigatran, rivaroxaban, apixaban, edoxaban (for thinning the blood).
• 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).
• 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).
• 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).
• 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.

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, you must tell your doctor or nurse before you are given this medicine, as the safety of clarithromycin in pregnancy or breast-feeding is not known.

Driving and using machines

This medicine may make you feel dizzy or drowsy. If it affects you in this way, you should not drive or use machines, or do anything that requires you to be alert.

Clarithromycin Infusion contains sodium

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

3. How Clarithromycin Infusion is given

Adults and children over 12 years

The recommended dose is 1.0 gram per day, split into two doses, for 2 to 5 days.

Your doctor will work out the correct dose for you.

Children under 12 years should not be given Clarithromycin Infusion. Your doctor will prescribe another suitable medicine for your child.

If a child accidentally swallows some of this

medicine, seek medical advice urgently.

If you are given more Clarithromycin

Infusion than you should have

As this medicine is given to you by a doctor, an

overdose is unlikely but symptoms may include

vomiting and stomach pains.

4. Possible side effects

Like all medicines, Clarithromycin Infusion can

cause side effects, although not everybody gets

them.

If you suffer from any of the following at any

time during your treatment tell your doctor

immediately as your treatment may need to be

stopped:

• 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

Very common side effects (may affect more

than 1 in 10 people)

• injection site phlebitis

Common side effects (may affect up to 1 in 10

people)

• inflammation, tenderness or pain at the site of

  injection

• difficulty sleeping
• changes in sense of taste
• headache
• widening of blood vessels (causing redness)

• stomach problems such as feeling sick,

  vomiting, stomach pain, indigestion, diarrhoea

• increased sweating

Uncommon side effects (may affect up to 1 in

100 people)

• 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

  000000.00

  • 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)
• convulsions (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, pharmacist or nurse. 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 Clarithromycin Infusion

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

Do not use Clarithromycin Infusion after the expiry date which is printed on the label and carton after EXP. The expiry date refers to the last day of that month.

Store in the original package.

Your doctor, pharmacist or nurse will know how to store Clarithromycin Infusion properly.

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 Infusion contains:

• The active substance is Clarithromycin 500 mg.
• The other ingredients are lactobionic acid, sodium hydroxide and hydrochloric acid (for pH adjustment).

What Clarithromycin Infusion looks like and contents of the pack

Clarithromycin Infusion is a vial containing a white to off-white powder.

Each vial contains 500 mg clarithromycin as clarithromycin lactobionate. Each carton contains 1 vial.

The reconstituted product is a clear solution.

Marketing Authorisation Holder

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Rua Bernardim Ribeiro, n. º 10-B, R/C Esquerdo 2700-111 Amadora

Portugal

Manufacturer

Sofarimex - Indústria Química e Farmacêutica, S.A. Avenida Das Indústrias, Alto De Colaride, 2735-213, Agualva-Cacém

Portugal

This leaflet was last revised in 07/2026.

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INFORMATION FOR THE HEALTHCARE PROFESSIONAL

The following information is intended for medical or healthcare professionals only

Instructions for use and handling

Reconstitution (Step 1)

Reconstitute each vial with 10 ml sterile water for injections. Shake until the vial contents have dissolved. Use only sterile water for injections, as other diluents may cause precipitation during reconstitution. Do not use diluents containing preservatives or inorganic salts. Each ml contains 50 mg clarithromycin.

Dilution (Step 2)

The reconstituted solution should be added to a minimum of 250 ml of one of the following diluents before administration: 5% dextrose, Lactated Ringer's, 0.9% sodium chloride, 5% dextrose in Lactated Ringer’s Solution, 5% dextrose in 0.3% sodium chloride, and 5% dextrose in 0.45% sodium chloride.

Each 1 ml of the infusion solution prepared in this way contains 2 mg clarithromycin. Compatibility with other IV additives has not been established.

IMPORTANT: BOTH DILUENT STEPS (1 and 2) SHOULD BE COMPLETED BEFORE USE.

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Clarithromycin 500 mg Powder for concentrate for Solution for Infusion should be administered into one of the larger proximal veins as an IV infusion over 60 minutes, using a solution concentration of about 2 mg/ml. Clarithromycin should not be given as a bolus or an intramuscular injection.

For single use only. The vial and any unused solution should be disposed of in accordance with local requirements.

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25ºC or for 48 hours at 2-8°C when reconstituted in 10 ml water for injections. Diluted solution:

• Chemical and physical in-use stability has been demonstrated for 24 hours at 25ºC or for 48 hours at 2-8ºC for the reconstituted solution after dilution with 0.9% sodium chloride solution.
• Chemical and physical in-use stability has been demonstrated for 48 hours at 25ºC or at 2-8ºC for the reconstituted solution after dilution with 5% dextrose or with Lactated Ringer's.
• Chemical and physical in-use stability has been demonstrated for 6 hours at 25ºC or for 48 hours at 2-8ºC for the reconstituted solution after dilution with 5% dextrose in Lactated Ringer’s Solution, 5% dextrose in 0.3% sodium chloride and 5% dextrose in 0.45% sodium chloride.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless reconstitution/ dilution has taken place in controlled and validated aseptic conditions.

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CLARITROMICINA 500MG LIOF UK MA 400 LIOF

480x140mm

Pant. 288 C

(TFE/SFX) AZEVEDOS

FOLDED LEAFLET Folded Size: 30x140 mm Paper IOR: 50 gr/m²

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