ERREMAN

Patient Information Leaflet: Information for the User

ERREMAN 10 mg tablets, 20 mg tablets

Manidipine
Generic medicine
Please read this leaflet carefully before taking this medicine, as 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 others, even if their symptoms are the same as yours, because it could 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 ERREMAN is and what it is used for
2. What you need to know before taking ERREMAN
3. How to take ERREMAN
4. Possible side effects
5. How to store ERREMAN
6. Contents of the pack and other information

What ERREMAN is and what it is used for
ERREMAN contains an active substance called manidipine hydrochloride. Manidipine hydrochloride belongs to a group of medicines known as calcium channel blockers, which block the flow of calcium into smooth muscle cells of blood vessels, causing vasodilation and a consequent reduction in blood pressure.
ERREMAN is used for the treatment of hypertension (mild to moderate hypertension).

2. What you need to know before taking ERREMAN

Do not take ERREMAN:

• if you are allergic to manidipine or to other calcium channel blockers or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney problems.
• if you have heart problems, for example if you have had a heart attack less than 4 weeks ago, or if you suffer from unstable angina pectoris (chest pain due to inadequate oxygen supply to the heart) or untreated heart failure.
• if you have mild or severe liver problems.

ERREMAN must not be administered to children and adolescents under 18 years of age.
Warnings and precautions
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Talk to your doctor or pharmacist before taking ERREMAN.
If you have known heart problems (e.g., left ventricular dysfunction, left ventricular outflow tract obstruction, right heart failure, or in patients with untreated sinoatrial node dysfunction not treated with a pacemaker).

• If you suffer from coronary disorders.
• If you are elderly or have mild liver problems (see section 3 “How to take ERREMAN”).

You should also inform your doctor:

• if you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding (see section “Pregnancy and breastfeeding”).

Other medicines and ERREMAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important to inform your doctor if you are taking any of the following medicines:

• diuretics (used to eliminate water from the body by increasing urine production) and other medicines that lower blood pressure, such as β-blockers and any other antihypertensive drugs. Indeed, these medicines may enhance the antihypertensive effect of ERREMAN. Medicines that affect the metabolism of the active substance in ERREMAN, such as antiprotease agents, cimetidine (used to treat gastric ulcers), or certain antibiotics (used to treat bacterial conditions, such as clarithromycin, erythromycin and rifampicin), or some antifungals (used to treat fungal infections, such as ketoconazole and itraconazole), or phenytoin, carbamazepine, phenobarbital, terfenadine and astemizole, or class III antiarrhythmics used for heart rate disorders (such as amiodarone and quinidine).
• Medicines containing digoxin, used to treat heart disorders.

If you are taking any of the medicines listed above, your doctor may prescribe you an alternative medicine or adjust the dose of ERREMAN or of the other medicine.
ERREMAN with food, beverages and alcohol
Do not take ERREMAN with grapefruit juice, as this may cause your blood pressure to drop too much.
Drinking alcohol may intensify the blood pressure lowering effect of ERREMAN.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Tell your doctor if you are pregnant, think you may be pregnant, or are planning a pregnancy.
Since ERREMAN must not be taken during pregnancy, your doctor will advise you to discontinue treatment before becoming pregnant or as soon as you know you are pregnant, and will prescribe appropriate therapy.
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Breastfeeding
Tell your doctor if you are breastfeeding or about to start breastfeeding.
Since ERREMAN should be avoided during breastfeeding, your doctor will advise you to stop breastfeeding if treatment with ERREMAN is absolutely necessary.
Driving and using machines
Occasionally, dizziness may occur in some people during antihypertensive treatment. If this happens to you, you should inform your doctor before engaging in activities such as driving or operating machinery.
ERREMAN contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take ERREMAN

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Dose
Initially, the recommended dose of Erreman is 10 mg once daily. After 2–4 weeks
of treatment, if the reduction in blood pressure is insufficient, your doctor may
increase the dose up to 20 mg once daily (usual maintenance dose).
ERREMAN must not be administered to children and adolescents (see section “Do not
take ERREMAN”).
Dose reduction
If you are elderly or suffer from renal or hepatic impairment, your doctor may prescribe an appropriately reduced dose.
Administration
Erreman should be taken in the morning after breakfast. The tablet should be swallowed with a sufficient amount of water, without chewing.
Try to take your daily dose at the same time each day.
The break line is intended to facilitate splitting the tablet if you have difficulty swallowing it whole.
Duration of treatment
It is important that you continue taking Erreman for as long as your doctor considers it necessary.
Always take exactly the prescribed dose and do not change it without first discussing it with your doctor.
If you take more ERREMAN than you should
If you accidentally take too many tablets, contact your doctor immediately, as this may cause an abnormally low blood pressure.
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If you forget to take ERREMAN
If you accidentally forget to take a dose of ERREMAN, take the next dose as usual.
Do not take a double dose to make up for the forgotten dose.
If you stop taking ERREMAN
It is important that you continue taking Erreman for as long as your doctor considers it necessary.
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 experiences them. If any side effects occur, they are likely to be mild and temporary. Some side effects may be serious and require medical treatment.

Common side effects (may occur in more than 1 in 100 patients, but in fewer than 1 in 10):
headache (cephalalgia), dizziness, vertigo, swelling caused by fluid retention (oedema), awareness of heartbeat (palpitations), hot flushes.

Uncommon side effects (may occur in more than 1 in 1,000 patients, but in fewer than 1 in 100):
tingling or painful numbness (paraesthesia), weakness (asthenia), increased heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing (dyspnoea), nausea, vomiting, constipation, dry mouth, digestive disturbances, skin rash, skin inflammation with redness and itching (eczema), transient changes in certain blood test enzymes (SGPT, SGOT, LDH, gamma-GT, alkaline phosphatase, blood urea nitrogen and serum creatinine).

Rare side effects (may occur in more than 1 in 10,000 patients, but in fewer than 1 in 1,000):
drowsiness, chest pain, chest pain due to inadequate blood flow to the heart (angina pectoris), increased blood pressure (hypertension), stomach pain (gastralgia), abdominal pain, skin redness (erythema), itching and irritability, diarrhoea, loss of appetite (anorexia), yellowing of the skin and eyes (jaundice), changes in certain blood tests (e.g. increased bilirubinaemia).

Very rare side effects (may occur in fewer than 1 in 10,000 patients):
heart attack.

In isolated cases, patients with pre-existing angina pectoris may experience an increase in frequency, duration and intensity of angina attacks. Inflammation and swelling of the gums (gingivitis and gingival hyperplasia), which usually resolve after discontinuation of treatment but require careful dental hygiene.

Side effects not known: frequency cannot be estimated from the available data.
Abnormal skin redness (erythema multiforme), skin disorders with abnormal redness and peeling (exfoliative dermatitis), muscle pain, breast swelling with or without breast tenderness in men (gynaecomastia).

Reporting of side effects
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If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 ERREMAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 ERREMAN 10 mg contains

• The active substance is manidipine hydrochloride 10 mg.
• The other ingredients are: monohydrate lactose, maize starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.

What ERREMAN 20 mg contains

• The active substance is manidipine hydrochloride 20 mg.
• The other ingredients are: monohydrate lactose, maize starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.

Description of the appearance of ERREMAN and contents of the pack
ERREMAN is available in two dosage strengths: 10 mg and 20 mg.
The 10 mg tablets are round, convex, yellow in colour, with a central break line.
The 20 mg tablets are oval, convex, yellow in colour, with a central break line.
ERREMAN is available in the following pack sizes:
10 mg 28 tablets
20 mg 28 tablets.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Pharmacare S.r.l.
Via Marghera, 29
20149 Milan, Italy
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Manufacturer:
Abiogen Pharma SpA
Via Meucci 36,
56014 Ospedaletto
Pisa - Italy
Doppel FARMACEUTICI S.r.l.
Via Volturno, 48
Quinto de’ Stampi
20089 Rozzano (MI)
Italy
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