Clarithromycin HCS

Package leaflet: Information for the patient

Clarithromycin HCS 250 mg film-coated tablets, 500 mg film-coated tablets

Clarithromycin
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Clarithromycin HCS is and what it is used for
2. What you need to know before taking Clarithromycin HCS
3. How to take Clarithromycin HCS
4. Possible side effects
5. How to store Clarithromycin HCS
6. Contents of the pack and other information

1. What Claritromicina HCS is and what it is used for

Clarithromycin belongs to a group of medicines called macrolide antibiotics.
Antibiotics block the growth of bacteria that cause infections.
Claritromicina HCS is used in adults and children aged 12 years and over to treat the following infections:

• Lung infections such as bronchitis and pneumonia,
• Infections of the throat and nose,
• Skin and soft tissue infections,
• Infections associated with Helicobacter pylori in duodenal ulcers.

2. What you should know before taking Clarithromycin HCS

Do not take Clarithromycin HCS if:

• you are allergic to clarithromycin, to other macrolide antibiotics such as erythromycin or azithromycin, or to any of the excipients of this medicine.
• you are taking medicines called ergot alkaloids, for example ergotamine or dihydroergotamine tablets, or using ergotamine inhalers for migraine. Ask your doctor for advice regarding alternative medicines.
• you are taking medicines called simvastatin or lovastatin (commonly known as statins, used to lower elevated blood lipids such as cholesterol and triglycerides).
• you are taking medicines called terfenadine or astemizole (for hay fever or allergies) or cisapride (for stomach disorders) or pimozide tablets (for mental health conditions), as the combination of these medicines may sometimes cause serious disturbances in heart rhythm. Ask your doctor for advice regarding alternative medicines.
• you are taking other medicines known to cause serious disturbances in heart rhythm.
• you are taking medicines called ticagrelor or ranolazine (for angina or to reduce the risk of heart attack or stroke).
• you are taking a medicine called colchicine (for gout).
• you have abnormally low levels of potassium in your blood (hypokalaemia).
• you are taking oral midazolam (for epilepsy).
• you have kidney and/or liver problems.
• you or a family member has a history of heart rhythm disturbances (ventricular arrhythmia, including torsades de pointes) or an abnormality on the electrocardiogram (ECG, electrical recording of the heart) called "long QT syndrome".

Clarithromycin HCS 250 mg, 500 mg film-coated tablets are not suitable for use in children under 12 years of age.
Warnings and precautions
Tell your doctor or pharmacist before taking Clarithromycin HCS.

• If you have heart problems.
• If you are pregnant or breastfeeding.
• If you need to take intravenous midazolam.
• If you have abnormally low levels of magnesium in your blood (hypomagnesaemia).

If you develop severe or prolonged diarrhoea during or after taking Clarithromycin HCS,
inform your doctor immediately, as it may be a symptom of a more serious condition
such as pseudomembranous colitis or Clostridium difficile-associated diarrhoea.
If you experience any symptoms of liver dysfunction such as anorexia (loss of appetite),
yellowing of the skin or whites of the eyes, dark urine, itching, or a tender abdomen,
stop taking Clarithromycin HCS and inform your doctor immediately.
Inform your doctor before taking Clarithromycin HCS if you have kidney problems.
Prolonged use of Clarithromycin HCS may lead to infections resistant to bacteria and fungi.
Children and adolescents
Clarithromycin HCS is not suitable for use in children under 12 years of age.
Other medicines and Clarithromycin HCS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are taking medicines called:

• digoxin, quinidine or disopyramide (used to treat heart problems). Your heart should be monitored (ECG test), or you may need blood tests if you are taking clarithromycin with any medicine used to treat heart conditions.
• warfarin, or any anticoagulant (used to thin the blood). Blood tests may be needed to check that your blood is clotting properly.
• omeprazole (used to treat indigestion or stomach ulcers), unless your doctor has prescribed it specifically for the treatment of Helicobacter pylori infection associated with duodenal ulcer.
• ergot alkaloids such as ergotamine or dihydroergotamine (for the treatment of migraine).
• colchicine (for the treatment of gout). Your doctor may monitor you.
• theophylline (used in patients with breathing difficulties such as asthma).
• terfenadine or astemizole (for hay fever or allergies).
• triazolam, alprazolam or midazolam (sedatives).
• cilostazol (for poor circulation).
• cisapride or cimetidine (for stomach problems).
• carbamazepine, valproate, phenytoin or phenobarbital (for the treatment of epilepsy).
• methylprednisolone (a corticosteroid).
• vinblastine (for the treatment of cancer).
• cyclosporine, tacrolimus or sirolimus (immunosuppressants used for organ transplantation and severe eczema).
• pimozide or St. John’s wort (for mental health conditions).
• rifabutin, rifampicin, rifapentine, fluconazole and itraconazole (for the treatment of infectious diseases).
• verapamil, amlodipine or diltiazem (for high blood pressure).
• tolterodine (for overactive bladder).
• simvastatin and lovastatin (known as HMG-CoA reductase inhibitors for the treatment of high cholesterol).
• ritonavir, efavirenz, nevirapine, atazanavir, saquinavir, etravirine and zidovudine (antiviral or anti-HIV medicines).
• sildenafil, vardenafil and tadalafil (for erectile dysfunction in adult males or used for pulmonary arterial hypertension – high blood pressure in the blood vessels of the lungs).
• insulin, repaglinide, rosiglitazone, pioglitazone, or nateglinide (medicines for the treatment of diabetes).
• aminoglycosides (a type of antibiotic) such as gentamicin, streptomycin, tobramycin, amikacin, netilmicin.

Clarithromycin HCS with food and drink
Clarithromycin HCS can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
The safety of using clarithromycin during pregnancy and breastfeeding has not been established. Therefore, its use during pregnancy is not recommended unless the benefits are carefully weighed against the risks. Clarithromycin is excreted in breast milk.
Driving and using machines
Clarithromycin HCS may cause dizziness, vertigo, confusion and disorientation. If you experience these symptoms, do not drive or operate machinery.
Clarithromycin HCS contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

3. How to take Claritromycin HCS

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
For lung infections, throat or sinus infections, and skin and soft tissue infections:
The usual dose of Claritromycin HCS film-coated tablets for adults and children over 12 years of age is 250 mg twice daily for 6–14 days, e.g. one film-coated tablet of Claritromycin HCS 250 mg in the morning and one in the evening.
Your doctor may increase the dose to one film-coated tablet of Claritromycin HCS 500 mg twice daily in severe infections.
Claritromycin HCS tablets should be swallowed whole with at least half a glass of water.
For the treatment of Helicobacter pylori infections associated with duodenal ulcer:
There are several effective combination therapies available for the treatment of Helicobacter pylori, in which Claritromycin HCS tablets are taken together with one or two other medicines.
The combinations include the following:
a) one tablet of Claritromycin HCS 500 mg taken twice daily, together with amoxicillin 1000 mg twice daily and lansoprazole 30 mg twice daily.
b) one tablet of Claritromycin HCS 500 mg taken twice daily, together with lansoprazole 30 mg twice daily and metronidazole 400 mg twice daily.
c) one tablet of Claritromycin HCS 500 mg taken twice daily, together with amoxicillin 1000 mg twice daily or metronidazole 400 mg twice daily plus omeprazole 40 mg once daily.
d) one tablet of Claritromycin HCS 500 mg taken twice daily, together with amoxicillin 1000 mg twice daily plus omeprazole 20 mg once daily.
e) one tablet of Claritromycin HCS 500 mg taken three times daily together with omeprazole 40 mg once daily.
The combination treatment you receive may differ slightly from those listed above. Your doctor will decide which combination is most suitable for you. If you are unsure which tablets you should take or for how long, ask your doctor for advice.
Use in children and adolescents
Do not give these tablets to children under 12 years of age. Your doctor will prescribe a suitable medicine for your child.
If you take more Claritromycin HCS than you should
If you accidentally take more tablets in one day than prescribed by your doctor, or if a child accidentally swallows some tablets, contact your doctor or the nearest hospital emergency department immediately. An overdose of Claritromycin HCS tablets is likely to cause vomiting and stomach pain.
If you forget to take Claritromycin HCS
If you forget to take a tablet, take it as soon as you remember. Do not take more tablets in one day than prescribed by your doctor. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Claritromycin HCS
Do not stop treatment even if you feel better. It is important to take the tablets for the full duration prescribed by your doctor; otherwise, the condition may return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following conditions at any time during treatment, STOP TAKING THE TABLETS and contact your doctor immediately:

• severe or prolonged diarrhoea, which may contain blood or mucus. Diarrhoea may persist for more than two months after treatment with clarithromycin; in this case, you should still contact your doctor.
• skin rash, difficulty breathing, fainting, or swelling of the face and throat. These are signs of an allergic reaction.
• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, soft abdomen, or loss of appetite. These may be signs that the liver is not functioning properly.
• severe skin reactions such as blistering of the skin, mouth, lips, eyes, and genitals (symptoms of a rare allergic reaction known as Stevens-Johnson syndrome/toxic epidermal necrolysis); a red, scaly rash with pustule and blister formation (exanthematous pustulosis). The frequency of this reaction is not known (cannot be estimated from available data).
• muscle pain or weakness, known as rhabdomyolysis (a condition causing breakdown of muscle tissue which may lead to kidney damage).

Common: may affect up to 1 in 10 people

• sleep disturbances (insomnia)
• changes in taste sensation
• headache
• stomach problems such as feeling unwell, vomiting, stomach ache, indigestion, diarrhoea
• abnormal liver function tests in blood analyses
• skin rash, excessive sweating, hot flushes

Uncommon: may affect up to 1 in 100 people

• skin or vaginal infections, fungal infections (thrush)
• changes in white blood cell levels in the blood (which may make infections more likely)
• changes in platelet levels in the blood (increased risk of bruising, bleeding, blood clots)
• allergic reaction
• decreased appetite
• anxiety, nervousness, shouting
• fainting, dizziness, drowsiness, tremor, involuntary movements of the tongue, face, lips, or limbs
• sensation of spinning (dizziness), ringing in the ears, hearing loss
• fast or pounding heartbeat (palpitations), changes in heart rhythm, or cardiac arrest
• breathing problems (asthma), nosebleeds
• blood clots in the lungs
• stomach swelling, constipation, gas (flatulence), belching, heartburn, or anal pain
• inflammation of the lining of the stomach or oesophagus (the tube connecting the mouth to the stomach)
• mouth pain, dry mouth, inflammation of the tongue
• liver problems such as hepatitis or cholestasis, which may cause yellowing of the skin (jaundice), pale stools, or dark urine
• increased liver enzymes
• itching, hives, skin inflammation
• stiffness, pain, or spasms in muscles
• kidney problems such as elevated levels of protein normally excreted by the kidneys or increased levels of kidney enzymes
• fever, chills, weakness, fatigue, chest pain, or general feeling of being unwell
• abnormal blood test results

Not known: frequency cannot be estimated from available data

• infection of the colon
• skin infection
• psychiatric disorders, confusion, altered sense of reality, depression, disorientation, hallucinations (seeing things), abnormal dreams (nightmares), manic episodes
• seizures
• change or loss of sense of touch and/or taste
• paresthesia (tingling and burning sensation of the skin, numbness, pins and needles)
• deafness
• bleeding
• inflammation of the pancreas
• discoloration of the tongue, change in tooth colour
• liver failure, jaundice (yellowing of the skin)
• rare skin reactions such as DRESS (which may cause serious symptoms such as rash, fever, and internal organ inflammation)
• acne
• muscle disorders (myopathy)
• inflammation of the kidneys (which may cause swelling of the ankles and high blood pressure) or kidney failure

Contact your doctor immediately if you develop any of these symptoms or experience any unexpected or unusual symptoms.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clarithromycin HCS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Claritromycin HCS contains

• The active substance is clarithromycin. 250 mg: Each tablet contains 250 mg of clarithromycin. 500 mg: Each tablet contains 500 mg of clarithromycin.
• The other ingredients are microcrystalline cellulose, sodium croscarmellose, povidone K30, anhydrous colloidal silicon dioxide, magnesium stearate, talc, stearic acid in the tablet core, and titanium dioxide E171, hypromellose, yellow iron oxide E172, and propylene glycol in the tablet coating.

Description of the appearance of Claritromycin HCS and contents of the pack
250 mg: Film-coated, oval, biconvex tablets, slightly yellowish-brown, 15–15.2 mm in length and 8 mm in width.
500 mg: Film-coated, oval, biconv游戏副本