Claricule 500 mg Injection

CLARICULE contains the active ingredient clarithromycin. CLARICULE belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) that cause infections. CLARICULE is used whenever an intravenous (injection into the vein) antibiotic is required to treat severe infections. It is used to treat infections such as:

1. Chest infections such as bronchitis and pneumonia
2. Throat and sinus infections
3. Skin and tissue infections

You should not receive CLARICULE if you:

• know that you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients in CLARICULE.
• 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) as combining these medicines 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 and kidney disease.
• or someone in your family has a history of heart rhythm disorders (ventricular cardiac dysrhythmia, 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 being given CLARICULE.

• 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

CLARICULE is not suitable for use in children.

Other medicines and CLARICULE

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines (This includes complementary or traditional 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 (for blood thinning)
• carbamazepine, valproate, phenobarbitone 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, cariprazine, aripiprazole 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 breastfeeding

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 receiving the medicine as the safety of CLARICULE in pregnancy or breast-feeding is not known.

Driving and using machines

CLARICULE may cause dizziness and confusion. It is not always possible to predict to what extent CLARICULE may interfere with your daily activities. You should ensure that you do not engage in the above activities until you are aware of the measure to which CLARICULE affects you.

CLARICULE is prepared by your doctor or nurse by dissolving the powder in the vial in sterile water. The solution obtained is added to a larger volume of sterile liquid. CLARICULE is given to you slowly through a needle, into your vein over a period of at least an hour. The recommended dose of CLARICULE for adults is 1.0g 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 CLARICULE.

If you take more CLARICULE than you should

Since a healthcare professional will administer CLARICULE, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

CLARICULE can cause side effects. Not all side effects reported for CLARICULE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CLARICULE, please consult your health care provider for advice. 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 CLARICULE, 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).

Tell your doctor if you notice any of the following:

Frequent side effects:

• inflammation, tenderness or pain at the site of the injection
• 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

Less Frequent side effects:

• 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), CLARICULE may worsen these symptoms.

• raised abnormal kidney and liver function blood test and raised blood tests

• feeling weak, tired and having no energy

Frequency Unknown:

• 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 overexcitement)
• 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)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

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 to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of CLARICULE.

Store all medicines out of reach of children. Store below 30 0 C. Do not freeze. Store in the original package in order to protect from moisture. Protect from light / moisture.