0.2 mg and 0.4 mg film-coated tablets
moxonidine
What Moxonidine STADA is and what it is used for
Moxonidine Stada is a blood pressure-lowering agent. It belongs to a group of medicines called imidazoline receptor agonists. It binds to certain receptors in the brain and thereby reduces the activity of the nerves that regulate blood pressure.
Moxonidine Stada is used for:
- treatment of high blood pressure (mild to moderate hypertension ).
Moxonidine contained in Moxonidine Stada may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Moxonidine STADA
Do not use Moxonidine STADA
- if you are allergic to moxonidine or any of the other ingredients of this medicine (listed in section 6)
- if you suffer from any of the medical conditions and diseases listed below:
- diseases of the cardiac conduction system:
- sick sinus syndrome (a heart disease that results in abnormal or irregular heartbeats)
- AV block grade II (characterized by altered electrocardiogram ( ECG )) pattern and may result in complete cardiac arrest
- AV block grade III, also called complete cardiac arrest (which is characterized by altered ECG pattern, decreased heart rate, low blood pressure and poor blood circulation)
- slow heart rate ( bradycardia ), ie less than 50 beats / minute at rest
- heart failure (see section “Warnings and precautions”)
- diseases of the cardiac conduction system:
Warnings and cautions
Talk to your doctor or pharmacist before taking Moxonidine Stada.
Tell your doctor if you have or have had any of the following conditions or diseases:
- AV block grade I (a disorder of the heart’s conduction system which is characterized by altered electrocardiogram ( ECG ))
- severe coronary heart disease (a disease characterized by decreased blood supply to the heart, which can lead to a heart attack)
- unstable angina pectoris (angina, chest pain)
- moderate heart failure (a condition where the heart does not work properly, but where you feel good at rest and with light exertion)
If your kidneys do not work well (your doctor will measure this) the effect of Moxonidine Stada may be too strong. This is more likely to happen at the beginning of treatment. Your doctor will therefore adjust your dose more carefully.
Children and young people
Moxonidine Stada should not be given to children and adolescents under 16 years of age. Experience with the use of moxonidine in this age group is limited.
Other medicines and Moxonidine STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Moxonidine Stada with tricyclic antidepressants (medicines used to treat depression).
The use of other medicines to lower blood pressure (blood pressure-lowering medicines) increases the effect of moxonidine.
If you are taking Moxonidine Stada with a beta-blocker (medicines used to treat high blood pressure or heart failure ) and treatment needs to be stopped, you should first stop taking the beta-blocker to avoid a sudden increase in blood pressure. After a few days, you can then stop taking Moxonidine Stada.
Moxonidine Stada may increase the effect of tricyclic antidepressants, sedatives, alcohol, and sleeping pills. The numbing effect of benzodiazepines (sleeping pills and sedatives) may be increased if you take moxonidine at the same time. Especially if you are taking Moxonidine Stada with lorazepam (which belongs to the group of benzodiazepines ) it may slightly reduce your ability to perform mental (cognitive) tasks.
If you take Moxonidine Stada with medicines that are excreted by the kidneys, they may affect each other’s effects.
Tolazoline (a medicine used to dilate blood vessels) may reduce the effect of moxonidine.
Moxonidine STADA with food, drink and alcohol
Intake of food does not affect the effect of moxonidine.
Avoid alcohol use during treatment.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should not use Moxonidine Stada if you are pregnant, unless necessary. It is not known if moxonidine can harm your unborn baby.
Breast-feeding
Moxonidine is excreted in human milk. Therefore, you should not use Moxonidine Stada if you are breastfeeding. If treatment with Moxonidine Stada is necessary, you should stop breastfeeding.
Driving and using machines
Moxonidine Stada may cause drowsiness and dizziness. If you experience such side effects, you should avoid risky activities such as driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Moxonidine STADA contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Moxonidine STADA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Take Moxonidine Stada with a sufficient amount of water. You can take the tablets before, during, or after a meal.
Treatment with Moxonidine Stada should not be stopped too suddenly (see “If you stop taking Moxonidine Stada” below).
The recommended dose is:
Adult and elderly patients
The starting dose is 0.2 mg moxonidine in the morning. After 3 weeks, your doctor may increase this dose to 0.4 mg moxonidine daily. You can take this dose as a single dose in the morning or two divided doses per day (morning and evening).
If your symptoms do not subside after another three weeks, your doctor may increase the dose to the maximum daily dose of 0.6 mg. The highest dose should be divided into two doses (morning and evening). You should not take more than 0.4 mg moxonidine as a single dose or 0.6 mg moxonidine daily in two divided doses (morning and evening).
Patients with renal impairment
If your kidneys are not working well, your single dose should not exceed 0.2 mg moxonidine and your daily dose should not exceed 0.4 mg moxonidine.
Use for children and adolescents
Moxonidine Stada should not be used in children and adolescents under 16 years of age as experience is limited.
If you use more Moxonidine STADA than you should
Symptoms of overdose include headache, drowsiness/somnolence ( somnolence ), fatigue, upper abdominal pain, dizziness, feeling of weakness ( asthenia ), feeling of stiffness ( sedation ), low blood pressure ( hypotension ), nausea (vomiting), lower heart rate ( Brady ) and dry mouth.
If you forget to use Moxonidine STADA
Do not worry. Omit this dose and take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop using Moxonidine STADA
Do not stop taking Moxonidine Stada suddenly. It is recommended that treatment be phased out for 2 weeks to minimize the risk of a sudden rise in blood pressure. Ask your doctor for advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dry mouth, a feeling of weakness ( asthenia ), dizziness, and drowsiness/somnolence ( somnolence ) have been described as very common. These symptoms appear especially at the beginning of treatment and usually subside over time.
The following side effects have been observed in connection with the clinical trials performed:
Very common (may affect more than 1 user in 10):
- dry mouth
Common (may affect up to 1 in 10 people):
- headache
- dizziness or feeling that it is spinning
- drowsiness / somnolence ( somnolence )
- changed thought processes
- sleep disorders including insomnia
- nausea, vomiting, constipation, diarrhea, indigestion and other disorders of the gastrointestinal tract
- rash, itching
- feeling of weakness ( asthenia )
- back pain
- dilation of blood vessels ( vasodilation )
Uncommon (may affect up to 1 in 100 people):
- lower heart rate ( bradycardia )
- tinnitus _ _
- Depression
- anxiety
- concern
- a feeling of numbness ( sedation )
- allergic skin reactions
- edema (swelling of tissue ) in different parts of the body
- severe allergic reaction causing swelling, especially of face, tongue or throat ( angioedema )
- low blood pressure ( hypotension )
- drop in blood pressure when standing up ( orthostatic hypotension )
- fainting ( syncope )
- feeling of tingling ( paresthesia ) in arms and legs
- fluid retention
- loss of appetite ( anorexia )
- pain in salivary glands
- neck pain
- enlargement of the mammary glands in men ( gynecomastia )
- impotence and decreased sexual drive
- peripheral circulatory disorders
- dry itching or burning sensation in the eye
How to store Moxonidine STADA
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is moxonidine.
Each Moxonidine Stada film-coated tablet contains either 0.2 mg or 0.4 mg of moxonidine.
Other ingredients are:
Tablet core:
- lactose monohydrate
- crospovidone
- povidone K25
- magnesium stearate
Film coating:
- hypromellos
- macrogol 400
- red iron oxide (E172)
- titanium dioxide (E171)
What the medicine looks like and contents of the pack
Moxonidine Stada film-coated tablets are round, about 6 mm in diameter.
The 0.2 mg tablet is light pink and the 0.4 mg tablet is dark pink.
Moxonidine Stada is available in packs containing 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 400 (20 x 20, 10 x 40 as hospital pack) film-coated tablets in PVC / PVDC aluminum blisters.
or
Perforated single-dose blister (PVC / PVDC / Al) with 7×1, 10×1, 14×1, 20×1, 28×1, 30×1, 50×1, 56×1, 98×1, 100×1, 400 (20 x 20×1, 10 x 40×1 as hospital packaging) film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Sanico NV, Veedijk 59 Industrial Zone IV, 2300 Turnhout, Belgium
Centrafarm Services BV, Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands
STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna, Austria
LAMP San Prospero SpA, Via della Pace, 25 / A, 41030 – S. Prospero S / S, Italien, Modena
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark