Rilmenidine Grindeks

Leaflet attached to the packaging: patient information

Rilmenidine Grindeks, 1 mg, tablets

Rilmenidinum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rilmenidine Grindeks and what is it used for
• 2. Important information before taking Rilmenidine Grindeks
• 3. How to take Rilmenidine Grindeks
• 4. Possible side effects
• 5. How to store Rilmenidine Grindeks
• 6. Contents of the packaging and other information

1. What is Rilmenidine Grindeks and what is it used for

Rilmenidine Grindeks contains the active substance rilmenidine, which lowers blood pressure. After oral administration, it is rapidly absorbed, and the effect of the medicine lasts for 24 hours.
Rilmenidine Grindeks is used to treat high blood pressure (hypertension) in adults.

2. Important information before taking Rilmenidine Grindeks

When not to take Rilmenidine Grindeks

• if the patient is allergic to rilmenidine or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe depression,
• if the patient has been diagnosed with severe kidney function disorders (renal failure) (creatinine clearance <15 ml min),< li>
• if the patient is taking sultopride (used to treat mental disorders such as schizophrenia) at the same time (see also section 2: "When not to take Rilmenidine Grindeks"). In case of any doubts, consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Rilmenidine Grindeks, the patient should discuss it with their doctor, pharmacist, or nurse.
Never stop the treatment abruptly; if it is necessary to stop the treatment, the dose should be gradually reduced, according to the doctor's instructions.
The patient should tell their doctor if they have recently had a disease of the circulatory system (stroke, heart attack). The treatment should be carried out under constant medical supervision.
If the patient is elderly, they should be cautious, as their blood pressure may drop sharply when standing up, putting them at risk of falling.
In case of taking medicines used to treat heart failure (beta-adrenergic blockers) or depression (MAO inhibitors), the patient should consult their doctor, as it is not recommended to combine them with Rilmenidine Grindeks (see section "Rilmenidine Grindeks and other medicines").
The patient should avoid drinking alcohol while taking this medicine (see section "Rilmenidine Grindeks with alcohol").

Children and adolescents

Rilmenidine Grindeks is not recommended for children and adolescents.

Rilmenidine Grindeks and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking or have recently taken, as well as the medicines they plan to take.
The patient should not take Rilmenidine Grindeks with the following medicine (see also section 2: "When not to take Rilmenidine Grindeks"):

• sultopride (used to treat mental disorders such as schizophrenia).

The patient should tell their doctor if they are taking any of the following medicines, as their use in combination with Rilmenidine Grindeks is not recommended:

• beta-adrenergic blockers (bisoprolol, carvedilol, metoprolol) used to treat heart failure,
• oxibate sodium (used to treat narcolepsy),
• MAO inhibitors (used to treat depression).

The patient should inform their doctor about taking any of the following medicines, as special caution may be required:

• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
• beta-adrenergic blockers (used to treat high blood pressure, angina pectoris, conditions causing chest pain),
• medicines used to treat heart rhythm disorders (quinidine, hydroquinidine, disopyramide, amiodarone, dofetilide, ibutilide, sotalol),
• certain neuroleptics (sedative medicines used to treat mental disorders): chlorpromazine, levomepromazine, thioridazine, amisulpride, sulpiride, tiapride, droperidol, haloperidol, pimozide,
• halofantrine (an antiparasitic medicine used to treat malaria),
• mizolastine (used to treat allergic reactions, such as hay fever),
• moxifloxacin, erythromycin administered intravenously, spiramycin administered intravenously (antibiotics used to treat infections),
• pentamidine (used to treat certain types of pneumonia),
• vincamine administered intravenously (used to treat symptoms of cognitive disorders in elderly patients, including memory disorders),
• bepridil (used to treat angina pectoris - a condition causing chest pain),
• cisapride, difemanil (used to treat gastrointestinal disorders),
• tricyclic antidepressants (used to treat depression),
• antihypertensive medicines other than Rilmenidine Grindeks (used to treat high blood pressure).

The patient should inform their doctor about taking any of the following medicines, as their use in combination with Rilmenidine Grindeks should be considered:

• alpha-adrenergic blockers (used to treat high blood pressure);
• amifostine (used in chemotherapy and radiotherapy);
• corticosteroids (used to treat various diseases, including severe asthma and rheumatoid arthritis), tetracosactide (used to treat Crohn's disease, oral administration) (except hydrocortisone used in Addison's disease);
• other neuroleptics (sedative medicines used to treat mental disorders), antidepressant medicines of the imipramine type (used to treat mental disorders, such as depression);
• other medicines that have a depressant effect on the central nervous system, which may impair concentration when used in combination with Rilmenidine Grindeks: morphine derivatives (painkillers, antitussives, and medicines used in substitution therapy for opioid dependence), medicines used to treat anxiety and sleep disorders (benzodiazepine derivatives, anxiolytics other than benzodiazepine derivatives, sleeping pills, neuroleptics), antagonists of the histamine H1 receptor with a sedative effect (used to treat allergies or allergic reactions), medicines used to treat depression (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), other centrally acting antihypertensive medicines, baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis), thalidomide (used to treat certain types of cancer), pizotifen, and indoramin (used to treat migraine attacks).

Rilmenidine Grindeks with alcohol

The patient should not drink alcohol during treatment.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Rilmenidine Grindeks is not recommended during pregnancy.
Breastfeeding
The patient should not take Rilmenidine Grindeks if they are breastfeeding. They should immediately inform their doctor if they are breastfeeding or plan to breastfeed.

Driving and operating machinery

Rilmenidine Grindeks may cause drowsiness, so the patient should be cautious when taking it, as it may impair their ability to drive vehicles and operate machinery.

3. How to take Rilmenidine Grindeks

This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of any doubts, the patient should consult their doctor or pharmacist.

Dosage

The medicine is intended only for adult patients.
The recommended dose is 1 tablet per day, taken as a single dose in the morning, before a meal. The tablets should be swallowed whole, with a glass of water.
If after a month of treatment, the blood pressure values do not normalize, the doctor may increase the dose to 2 tablets per day (1 tablet in the morning and 1 tablet in the evening), taken before meals.
Due to the fact that treatment with this medicine is well tolerated, rilmenidine may be prescribed to elderly patients and patients with diabetes.

Taking a higher dose of Rilmenidine Grindeks than recommended

In case of taking too many tablets, the patient may experience very low blood pressure and attention disorders. They should immediately contact their doctor or pharmacist.

Missing a dose of Rilmenidine Grindeks

In case of missing a dose, the patient should take the next dose at the usual time. They should not take a double dose to make up for the missed tablet.

Stopping treatment with Rilmenidine Grindeks

The patient should never stop taking this medicine abruptly; the doctor will gradually reduce the dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Rilmenidine Grindeks can cause side effects, although not everybody gets them.
If the patient experiences symptoms of slow heart rate (bradycardia), such as dizziness, fainting, or fatigue, they should contact their doctor.
The following side effects have been reported:

• anxiety, depression, insomnia,
• drowsiness, headache, dizziness,
• palpitations (feeling of heartbeat),
• feeling of cold in the hands and/or feet,
• stomach pain, dryness of the mucous membranes of the mouth, diarrhea, constipation,
• rash, itching,
• muscle cramps,
• sexual disorders,
• weakness, fatigue, swelling.

Uncommon (may affect up to 1 in 100 people):

• hot flashes, drop in blood pressure when standing up,
• nausea (nausea).

Rare (may affect up to 1 in 1,000 people):

• shortness of breath.

Frequency not known (cannot be estimated from the available data):

• slow heart rate (bradycardia).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Rilmenidine Grindeks

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP" and on the blister pack. The expiry date refers to the last day of the month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rilmenidine Grindeks contains

• The active substance of the medicine is rilmenidine. Each tablet contains 1 mg of rilmenidine, which corresponds to 1.544 mg of rilmenidine dihydrogen phosphate.
• The other ingredients are microcrystalline cellulose, crospovidone (type B), talc, magnesium stearate.

What Rilmenidine Grindeks looks like and contents of the pack

Rilmenidine Grindeks is a white, round, biconvex tablet. The diameter of the tablet is approximately 6 mm.
Rilmenidine Grindeks is available in blisters containing 30, 60, or 90 tablets, packed in cardboard boxes.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia
phone: +371 67083205
fax: +371 67083505
e-mail: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria:
Rilmenidin Grindeks 1 mg Tabletten
Bulgaria:
Рилменидин Гриндекс 1 мг таблетки
Czech Republic:
Rilmenidine Grindeks
Estonia:
Rilmenidine Grindeks
France:
Rilmenidine Grindeks 1 mg, comprimé
Lithuania:
Rilmenidine Grindeks 1 mg tabletės
Latvia:
Rilmenidine Grindeks 1 mg tabletes
Poland:
Rilmenidine Grindeks
Portugal:
Rilmenidine Grindeks 1 mg comprimidos
Romania:
Rilmenidină Grindeks 1 mg comprimate
Slovakia:
Rilmenidine Grindeks 1 mg tablety
Hungary:
Rilmenidine Grindeks 1 mg tabletta

Date of last revision of the leaflet: