ERREMAN 10 mg Таблетки

Содержание инструкции

1. ERREMAN 10 mg tablets, 20 mg tablets
   1. What you need to know before taking ERREMAN
   2. How to take ERREMAN
   3. Possible side effects
   4. How to store ERREMAN
   5. Contents of the pack and other information

ERREMAN 10 mg tablets, 20 mg tablets

Manidipine
Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 ingredient called manidipine hydrochloride, Manidipine hydrochloride
belongs to a group of medicines called calcium channel blockers, which
blocks the flow of calcium into the smooth muscle cells of blood vessels causing
vasodilation and a corresponding reduction in blood pressure.
ERREMAN is used for the treatment of hypertension (mild and moderate hypertension).

2. What you need to know before taking ERREMAN

Do not take ERREMAN:

• if you are allergic to manidipine or other calcium channel blockers or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from severe kidney problems.
• If you suffer from 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 suffer from untreated heart failure.
• If you suffer from mild or severe liver problems.

ERREMAN should not be administered to children and adolescents under 18
years of age.

Warnings and precautions
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Consult your doctor or pharmacist before taking ERREMAN.
If you suffer from confirmed heart problems (e.g. left ventricular heart failure, left ventricular outflow obstruction, right heart failure and in patients with untreated sinus node dysfunction with a pacemaker).

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

You should also tell your doctor:

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

Other medicines and ERREMAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
It is particularly important to tell 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 beta-blockers and any other antihypertensive drug. In fact, these medicines can intensify the antihypertensive effect of ERREMAN. Drugs that affect the metabolism of the active ingredient contained in ERREMAN, such as protease inhibitor drugs, cimetidine (used for the treatment of gastric ulcers), or certain antibiotics (used to treat bacterial infections, such as clarithromycin, erythromycin and rifampicin), or some antifungal drugs (used for the treatment of fungal infections, such as ketoconazole and itraconazole), or phenytoin, carbamazepine, phenobarbital, terfenadine and astemizole or class III antiarrhythmics used for heart rate problems (such as amiodarone and quinidine).
• Medicines containing digoxin, used for the treatment of heart disorders.

If you are taking any of the medicines mentioned above, your doctor may prescribe another
medicine or adjust the dosage of Erreman or the other medicine.

ERREMAN with food and drink and alcohol
Do not take Erreman with grapefruit juice as this may lower blood pressure
too much.
Drinking alcohol can intensify the blood pressure lowering effect obtained with Erreman.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Pregnancy
Tell your doctor if you are pregnant if you think you may be pregnant or if you are planning a pregnancy.
Since ERREMAN cannot be taken during pregnancy, your doctor will
advise you to stop treatment before becoming pregnant or as soon as you know you are
pregnant, and will prescribe the correct therapy.
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Breastfeeding
Tell your doctor if you are breastfeeding or planning to breastfeed.
Since ERREMAN should be avoided during breastfeeding, your doctor will
advise you to stop breastfeeding if treatment with ERREMAN is absolutely necessary.

Driving and operating machinery
Occasionally, dizziness may occur in some people during treatment
of hypertension. If this happens to you, you should inform your doctor before undertaking
activities such as driving and using machinery.
.

ERREMAN contains lactose.
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take ERREMAN

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
Dosage
Initially, the recommended dose of Erreman is 10 mg once a day. After 2-4 weeks
of treatment, if the reduction in blood pressure is insufficient, the doctor may
increase the dosage up to 20 mg once a day (usual maintenance dose).
ERREMAN should not be administered to children and adolescents (see section “Do
not take ERREMAN”).
Dose reduction
If you are elderly or if you suffer from kidney or liver disorders, your doctor may prescribe you a reduced
dose appropriately.
Administration
Erreman must be taken in the morning after breakfast. The tablet must be swallowed with a
sufficient amount of water, without chewing it.
You should try to take your daily dose at the same time each day.
The score line is to facilitate breaking the tablet, if you have difficulty
swallowing it whole.
Duration of treatment
It is important that you continue to take Erreman as long as your doctor deems it appropriate.
Always take exactly the same dose that has been prescribed to you, without changing it before
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 abnormal lowering of 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
normally.
Do not take a double dose to make up for a missed dose.

If you stop taking ERREMAN
It is important that you continue to take Erreman, as long as your doctor deems it appropriate.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If any of the side effects occur, they are likely to be mild and temporary. Some side effects may be
serious and require medical attention.

Common side effects (may affect more than 1 in 100 people, but less than 1 in 10):
headache, dizziness, vertigo, swelling caused by fluid retention (edema), feeling of a racing
heartbeat (palpitations), hot flushes.

Uncommon side effects (may affect more than 1 in 1,000 people, but less than 1 in 100):
tingling or painful numbness (paresthesia), weakness, increased heart rate (tachycardia), low
blood pressure (hypotension), shortness of breath (dyspnea), nausea, vomiting, constipation,
dry mouth, digestive disorders, skin rash, skin inflammation with redness and itching (eczema),
temporary changes in certain enzymes detectable in some blood tests (SGPT, SGOT, LDH, gamma-GT,
alkaline phosphatase, blood urea and creatinine).

Rare side effects (may affect more than 1 in 10,000 people, but less 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, diarrhea, loss of appetite (anorexia), yellowing of
the skin and eyes (jaundice), changes in some blood tests (e.g. increased bilirubinemia).

Very rare side effects (may affect less than 1 in 10,000 people):heart attack.
In isolated cases, in patients with pre-existing angina pectoris, an increase in the frequency,
duration and intensity of these attacks may occur. Inflammation and swelling of the gums
(gingivitis and gingival hyperplasia) which usually disappear after stopping treatment but require
thorough dental hygiene.

Side effects with unknown frequency:frequency cannot be estimated based on available data.
Abnormal skin redness (erythema multiforme), skin disorders with abnormal redness and
scaling (exfoliative dermatitis), muscle pain, breast enlargement with or without breast tenderness
in men (gynecomastia).

Reporting of side effects
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If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through 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 ERREMAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ERREMAN 10 mg contains

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

What ERREMAN 20 mg contains

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

Description of the appearance of ERREMAN and contents of the pack
ERREMAN is available in two dosages: 10 and 20 mg.
The 10 mg tablets are round, convex, yellow in colour, with a median fracture line.
The 20 mg tablets are oval, convex, yellow in colour, with a median fracture line.
ERREMAN is available in the following packs:
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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