Package leaflet: Information for the patient

Rilmenidine Grindeks, 1 mg, tablets
Rilmenidinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Rilmenidine Grindeks is and what it is used for
Important information before taking Rilmenidine Grindeks
How to take Rilmenidine Grindeks
Possible side effects
How to store Rilmenidine Grindeks
Contents of the pack and other information

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

2. Important information before taking Rilmenidine Grindeks

When not to take Rilmenidine Grindeks

if you are allergic to rilmenidine or any of the other ingredients of this medicine (listed in section 6),
if you have severe depression,
if you have severe kidney function impairment (renal failure) (creatinine clearance < 15 mL/min),
if you are taking medicines containing sultopride (used to treat psychiatric disorders such as schizophrenia) (see section “Rilmenidine Grindeks and other medicines”). If in doubt, please consult your doctor or pharmacist.

Warnings and precautions
Before starting treatment with Rilmenidine Grindeks, discuss it with your doctor, pharmacist, or nurse.
Never stop treatment abruptly; if discontinuation is necessary, the dose should be gradually reduced according to your doctor's instructions.
Tell your doctor if you have recently suffered from a cardiovascular disease (e.g. stroke, myocardial infarction). Treatment should be carried out under continuous medical supervision.
If you are elderly, you should be cautious, as your blood pressure may drop suddenly upon standing, increasing your risk of falling.
If you are taking medicines used to treat heart failure (beta-blockers) or depression (MAO inhibitors), consult your doctor, as their combination with Rilmenidine Grindeks is not recommended (see section “Rilmenidine Grindeks and other medicines”).
Avoid drinking alcohol while taking this medicine (see section “Rilmenidine Grindeks and alcohol”).

Children and adolescents
Rilmenidine Grindeks is not recommended for use in children and adolescents.

Rilmenidine Grindeks and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Rilmenidine Grindeks with the following medicine (see also section 2: “When not to take Rilmenidine Grindeks”):

sultopride (used to treat psychiatric disorders such as schizophrenia).

Tell your doctor if you are taking any of the following medicines, as their combination with Rilmenidine Grindeks is not recommended:

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

Inform your doctor if you are taking any of the following medicines, as special caution may be required:

baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis),
beta-blockers (used to treat hypertension, angina pectoris, conditions causing chest pain),
medicines used to treat cardiac arrhythmias (quinidine, hydroquinidine, disopyramide, amiodarone, dofetilide, ibutilide, sotalol),
certain neuroleptics (sedative medicines used to treat psychiatric 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, intravenous erythromycin, intravenous spiramycin (antibiotics used to treat infections),
pentamidine (used to treat certain types of pneumonia),
intravenous vinpocetine (used to treat cognitive symptoms in elderly patients, including memory disorders),
bepridil (used to treat angina pectoris – a condition causing chest pain),
cizapride, difemanil (used to treat gastrointestinal disorders),
tricyclic antidepressants (used to treat depression),
antihypertensive medicines other than Rilmenidine Grindeks (used to treat hypertension).

Inform your doctor if you are taking any of the following medicines, as their combination with Rilmenidine Grindeks should be considered:

alpha-blockers (used to treat high blood pressure);
amifostine (used in chemotherapy and radiotherapy);
corticosteroids (used to treat various conditions, including severe asthma and rheumatoid arthritis), tetracosactide (used to treat Crohn's disease, oral treatment) (except hydrocortisone used in Addison's disease);
other neuroleptics (sedative medicines used to treat psychiatric disorders), imipramine-type antidepressants (used to treat psychiatric disorders such as depression);
other medicines acting centrally on the nervous system, which may impair concentration when used concomitantly with Rilmenidine Grindeks: morphine derivatives (analgesics, antitussives, and medicines used in opioid substitution therapy), medicines used to treat anxiety and sleep disorders (benzodiazepine derivatives, non-benzodiazepine anxiolytics, hypnotics, neuroleptics), sedating H1 histamine receptor antagonists (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 conditions such as multiple sclerosis), thalidomide (used to treat certain cancers), pizotifen and indoramine (used to treat migraine attacks).

Rilmenidine Grindeks and alcohol
Do not drink alcohol during treatment.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Use of this medicine during pregnancy is not recommended.
Breastfeeding
Do not take Rilmenidine Grindeks if you are breastfeeding. Inform your doctor immediately if you are breastfeeding or intend to breastfeed.
Driving and using machines
Rilmenidine Grindeks may cause drowsiness; therefore, use with caution, as it may impair your ability to drive or 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 doubt, consult your doctor or pharmacist.
Dosage
This medicine is intended for adult patients only.
The recommended dose is 1 tablet per day, taken as a single morning dose immediately before a meal.
The tablets should be swallowed whole with a glass of water.
If blood pressure values have not normalized after one month of treatment, the doctor may increase
the dose to 2 tablets per day (1 tablet in the morning and 1 tablet in the evening), taken immediately
before meals.
Since treatment with this medicine is well tolerated, rilmenidine may be prescribed to elderly
patients and diabetic patients.
Taking more Rilmenidine Grindeks than recommended
If too many tablets are taken, the patient may experience very low blood pressure and disturbances
in attention. Seek immediate medical advice from a doctor or pharmacist.
Missing a dose of Rilmenidine Grindeks
If a dose is missed, take the next dose at the usual time. Do not take a double dose to make up for
the missed tablet.
Stopping Rilmenidine Grindeks
Do not stop taking this medicine suddenly. Your doctor will gradually reduce the dose.
If you have any further doubts regarding 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 everybody gets them.
If the patient experiences symptoms of slowed heart rate (bradycardia), such as dizziness,
fainting or fatigue, they should contact their doctor.
The following side effects have been reported:

Common (may affect up to 1 in 10 people):

anxiety, depression, insomnia,
drowsiness, headache, dizziness,
palpitations (awareness of heartbeat),
feeling of coldness in hands and/or feet,
stomach pain, dryness of the oral mucosa, diarrhoea, constipation,
rash, itching,
muscle cramps,
sexual disturbances,
weakness, fatigue, swelling.

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

hot flushes, drop in blood pressure upon standing,
nausea.

Rare (may affect up to 1 in 1000 people):

shortness of breath.

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

slowed heart rate (bradycardia).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Rilmenidine Grindeks

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

6. Contents of the package and other information

What Rilmenidine Grindeks contains

The active substance is rilmenidine. Each tablet contains 1 mg rilmenidine, equivalent to 1.544 mg rilmenidine dihydrogen phosphate.
The other components 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 tablet diameter is approximately 6 mm.
Rilmenidine Grindeks is available in blister packs containing 30, 60 or 90 tablets, packed in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries 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