Selviclor

Patient Information Leaflet: Information for the User

SELVICLOR 750 mg modified-release tablets

Cefaclor monohydrate
Generic medicine
Read this entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 SELVICLOR is and what it is used for
2. What you need to know before taking SELVICLOR
3. How to take SELVICLOR
4. Possible side effects
5. How to store SELVICLOR
6. Contents of the pack and other information

1. What SELVICLOR is and what it is used for

SELVICLOR contains the active substance cefaclor.
Cefaclor is an antibacterial agent belonging to the cephalosporin family. These
antibiotics exert a bactericidal action against pathogenic bacteria shown to be sensitive to
their effect. Their bactericidal action consists in preventing the formation of the cell wall in
certain bacterial strains.
SELVICLOR is indicated for the treatment of the following infections caused by susceptible strains:

• respiratory tract infections (pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis and tonsillitis);
• skin and soft tissue infections;
• urinary tract infections.

2. What you should know before taking SELVICLOR

Do not use SELVICLOR if:

• you are allergic to cefaclor, to other similar substances (cephalosporins), or to any of the other ingredients of this medicine listed in section 6;
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions:
Talk to your doctor or pharmacist before taking SELVICLOR:

• if you are allergic to antibiotics of the cephalosporin or penicillin classes. In such patients, administration of these antibiotics may cause severe sudden allergic reactions (anaphylactic reactions);
• if you have severe impairment of kidney function. Your doctor will determine the appropriate dose of SELVICLOR for your condition;
• if you have had or currently suffer from intestinal disorders, particularly colitis. Take SELVICLOR exactly as prescribed by your doctor.

While undergoing treatment with SELVICLOR, keep in mind that:

• episodes of diarrhoea may occur, as the use of broad-spectrum antibiotics (including macrolides, semisynthetic penicillins and cephalosporins) is often associated with pseudomembranous colitis (antibiotic-associated colitis);
• the safety of cefaclor during pregnancy has not been sufficiently established;
• this medicine must be kept out of the sight and reach of children;
• in case of an allergic reaction due to the use of cefaclor, stop treatment immediately and inform your doctor or go to the nearest hospital;
• prolonged use of cefaclor may lead to the development of antibiotic-resistant bacteria;
• if you develop additional infections beyond the one for which you are taking SELVICLOR, inform your doctor immediately, who will initiate the most appropriate treatment for your condition;
• if you undergo urine tests using Benedict's or Fehling's solutions or Clinitest, false positive results indicating the presence of glucose in urine may occur. This effect has not been observed with Tes-Tape® (enzymatic test for glycosuria, Lilly).

Other medicines and SELVICLOR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Inform your doctor if you are taking:

• probenecid (used in the treatment of gout). Concomitant use inhibits renal elimination of cefaclor.
• Absorption of SELVICLOR decreases if antacids containing magnesium or aluminium hydroxide are administered within one hour of taking the antibiotic.

SELVICLOR with food, beverages and alcohol
SELVICLOR may be taken regardless of meals.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take SELVICLOR if you are pregnant or breastfeeding, unless your doctor has evaluated whether the potential benefits outweigh the possible risks to you and your baby and considers it strictly necessary.
Driving and using machines
This medicine does not affect your ability to drive or operate machinery.

3. How to take SELVICLOR

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
SELVICLOR is administered orally and may be taken regardless of meals.

Adults:

• Pharyngitis, tonsillitis, and skin and soft tissue infections: 750 mg twice daily.
• Uncomplicated lower urinary tract infections: 750 mg twice daily.
• Bronchitis: 750 mg twice daily.

For the treatment of infections caused by S. pyogenes (group A streptococci), therapy with SELVICLOR should be continued for up to 10 days.

Instructions for use
The tablets must be taken whole and should not be split, crushed, or chewed.

If you take more SELVICLOR than you should
If you take an excessive dose of SELVICLOR, inform your doctor immediately or go to the nearest hospital. Always bring the package with you so that the medicine can be easily identified.
If you take an overdose of SELVICLOR, symptoms such as nausea, vomiting, epigastric discomfort, and diarrhea may occur. The severity of epigastric discomfort and diarrhea is related to the dose taken.
If other symptoms occur, they are likely secondary to the underlying disease, an allergic reaction, or another intoxication.

If you forget to take SELVICLOR
Do not take a double dose to make up for the missed dose.

If you stop taking SELVICLOR
Do not discontinue administration of the medicine without first consulting your doctor. Take SELVICLOR exactly as prescribed by your doctor.
It is important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop taking this medicine too early, the infection may not be completely cured, symptoms may recur or worsen, and you may develop antibiotic resistance.

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

4. Possible side effects

Like all medicines, SELVICLOR may cause side effects, although not everybody experiences
them.
If you experience any of the following serious side effects, stop taking
SELVICLOR immediately and contact your doctor or go to the nearest hospital :

• severe skin reaction with peeling and swelling of the skin, skin blisters, affecting mouth, eyes, genitals, frequent rashes with inflammation (Stevens-Johnson syndrome and toxic epidermal necrolysis);
• severe sudden-onset allergic reaction (anaphylaxis);
• sudden swelling of one or more of the following parts: hands, feet, lips, tongue, throat, which may cause breathing difficulties and/or itching, rash, due to an allergic reaction (angioedema);
• severe kidney problems (interstitial nephritis).

Other side effects that may occur with the use of SELVICLOR

• allergic reactions, rare (affects up to 1 in 1,000 people): itching, urticaria, positive Coombs test;
• erythema multiforme, rash and other skin manifestations, accompanied by joint pain and inflammation (arthritis/arthralgia), with or without fever, known as serum-sickness-like diseases;
• diarrhoea, antibiotic-associated colitis (pseudomembranous colitis), nausea, vomiting;
• genital itching, fungal vaginal infections and vaginitis;
• changes in blood cell count (eosinophilia, thrombocytopenia);

Side effects that may occur with the use of antibiotics of the cephalosporin class:

• liver problems and yellowing of the skin and whites of the eyes (cholestatic jaundice);
• anaemia;

For the following side effects, it is not certain whether there is a correlation with the use of SELVICLOR

• hyperactivity, restlessness, insomnia, mental confusion, increased muscle tone, hallucinations, sensation of unsteadiness and staggering, drowsiness.
• transient changes in blood test values such as:
• slight increases in liver enzyme values (SGOT and SGPT, or alkaline phosphatase) (1 in 40);
• changes in blood cell count (transient lymphocytosis, leucopenia and, rarely, haemolytic anaemia, aplastic anaemia, agranulocytosis and reversible neutropenia of possible clinical significance), prolonged prothrombin time, with or without clinical bleeding, in patients receiving cefaclor and sodium warfarin concurrently;
• slight increases in blood urea nitrogen or creatinine (less than 1 in 500) or abnormalities in urine analysis (less than 1 in 200).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You may also report side effects directly via the national reporting system at the following
website:
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SELVICLOR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after 'Exp'.
The expiry date refers to the last day of that month.
This date applies to the product in its original, undamaged packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

Description of the appearance of SELVICLOR and contents of the pack
SELVICLOR 750 mg modified-release tablets
is packaged in blisters within a printed cardboard carton containing 6 modified-release tablets.

Marketing Authorization Holder and Manufacturer
MARKETING AUTHORIZATION HOLDER
Lanova Farmaceutici S.r.l
Via Conca d’oro 212
00141 Roma
Italy

MANUFACTURER
FACTA FARMACEUTICI S.p.A.
Via Laurentina Km 24,730 - 00040 Pomezia (Roma)