Moxogamma 0.3 mg. 30 tablets

What Moxogamma is and what it is used for
Pharmacotherapeutic group or mode of action
Moxogamma 0.3 mg film-coated tablets is a centrally acting medicinal product for lowering high blood pressure.

Therapeutic indications
Moxogamma 0.3 mg film-coated tablets is used to treat mild to moderate high blood pressure with unknown cause (essential hypertension).

2. What you need to know before you take Moxogamma
Do not take Moxogamma:

if you are allergic to moxonidine or any of the other ingredients of this medicine (listed in section 6);
if you have a sinus nodule syndrome (a type of heart rhythm disorder where impulses are formed in the sinus node of the heart is irregular / non-rhythmic);
if your heart rate, measured at rest, is very slow (less than 50 beats per minute);
if you have a grade II or III AV block (severe electrical conduction disturbances passing from the upper to lower heart sections);
if you have heart failure.
Warnings and precautions:

Talk to your doctor or pharmacist before taking Moxogamma:

if you have an I degree AV block. In this case, an abnormal delay in heart rate may occur;
if you suffer from severe coronary heart disease or unstable angina pectoris;
if you suffer from a kidney function disorder. In this case, regular and often controlled control of the blood pressure lowering effect of Moxogamma 0.3 mg is necessary, especially at the beginning of treatment. As a next step, it is necessary to carefully determine the dosage;
if you are also taking a beta-blocker. If this treatment is to be stopped, treatment with the beta-blocker should be discontinued gradually and, after a few days, stopping the Moxogamy. This avoids an excessive increase in blood pressure;
if you are elderly. Your doctor may start treatment with the lowest dose and gradually increase it;
if you suffer from intolerance to lactose, lactase deficiency or glucose-galactose malabsorption.
You should not discontinue abruptly taking Moxogamma 0.3 mg film-coated tablets. At your doctor's discretion, this should take a slow and gradual end of treatment for two weeks (see also section "How to take Moxogamma").

Children and adolescents
Moxogamma 0.3 mg should not be used in children and adolescents under 16 years of age because there is currently insufficient experience of administering the drug to this age group.

Elderly patients
If renal function is not impaired, there is no need to reduce the doses of Moxogamma 0.3 mg in the elderly.

Other medicines and Moxogamma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Other antihypertensive medicines (lower blood pressure medicines)
The lowering effect on blood pressure is enhanced.

Drugs for the suppression of anxiety states and states of tension (tranquillizers), sleeping and sedating agents
The effect of these drugs is increased.

Tricyclic antidepressants (a type of medicine to treat depression)
The effect of these drugs is increased.

Benzodiazepines (a type of sedative and / or sleeping medicines)
The effect of these drugs is increased.

Lorazepam (benzodiazepine, which is a soothing agent)
A slight decrease in the function of the brain.

Tolazoline (a vasodilating medicine) can dose-dependently weaken the effect of Moxogamma.

Moxogamma is excreted from the body through the kidneys as so-called "tubular excretion." Other drugs that are similarly released by the kidneys may affect the action of Moxonidine.

Moxogamma with food, beverages and alcohol
Do not consume alcohol while taking Moxogamma, as Moxogamma may increase the effect of alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
In view of the insufficient data on the use of Moxonidine in pregnant women, the use of Moxogamma 0.3 mg during pregnancy is only allowed after the physician assesses the benefit-risk balance.

Breastfeeding
As moxonidine (the active substance) is passed into breast milk, Moxoxam 0.3 mg should not be taken during breast-feeding.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed, but dizziness and dizziness have been reported. You should keep this in mind when doing such activities.

Moxogam 0.3 mg film-coated tablets contains lactose monohydrate.
If you have an intolerance to certain types of sugars, you can take Moxogamma 0.4 mg only after talking to your doctor.

3. How to take Moxogamma
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Application method
For oral use
Take Moxogamma 0.3 mg before, during or after a meal with a sufficient amount of liquid (eg a glass of water).

Note:
There are also Moxogamma 0.2 mg film-coated tablets as well as Moxogamma 0.4 mg film-coated tablets.

The recommended dose is:
Adults
Treatment should be initiated at a dose of 0.2 mg of moxonidine in the morning.
If the therapeutic effect is insufficient, the dosage may be increased to 0.4 mg after a three-week interval. The intake may be given as a single dose or divided into two doses per day (morning and evening).
If after 3 weeks of treatment the results are still unsatisfactory, the dosage may be increased to a maximum of 0.6 mg (corresponding to 2 film-coated tablets Moxogamma 0.3 mg). The daily dose should be divided into two doses (morning and evening).
Do not exceed the single dose of 0.4 mg of Moxonidine and the daily dose of 0.6 mg of Moxonidine (corresponding to 2 film-coated tablets Moxogamma 0.3 mg).

Elderly patients
If the renal function is not impaired, the adult dose is valid.

Impaired kidney function
Patients with moderate renal impairment:
Maximum unit dose: 0.2 mg of Moxonidine.
Maximum daily dose: 0.4 mg of Moxonidine.

Patients with severe renal impairment:
Maximum unit dose: 0.2 mg of Moxonidine.
Maximum daily dose: 0.3 mg of Moxonidine (corresponding to 1 film-coated tablet Moxogamma 0.3 mg).

Hepato-biliary disorders
Patients with mild to moderate hepatic impairment
Apply the same dosage recommendations as for adults.

If you take more Moxogamma than you should
Signs of overdose in young children may be:
Sedation, pupillary contraction, decrease in blood pressure, difficulty in breathing, coma.

Signs of overdose in adults may be:
Headache, sedation, low blood pressure, orthostatic hypotension (decrease in blood pressure when changing the body position), drowsiness, dizziness, weakness, unusual delay of heartbeat, dry mouth, fatigue, upper abdominal pain , vomiting. In rare cases, a paradoxical rise in blood pressure may occur. In cases of severe overdosage, consciousness disturbances and severe breathing problems may occur.
Data from some high-dose studies in animals: Transient hypertension, tachycardia and hyperglycaemia may occur.

In the event of an overdose, you should immediately inform your doctor. He / she should take the necessary action, eg. measures to stabilize blood circulation.

If you forget to take Moxogamma
Do not take a double dose to make up for the missed dose.

If you stop taking Moxogamma
Treatment should not be abruptly discontinued.
Please do not interrupt or discontinue Moxogamma at your own initiative without your doctor's express indication.
Moxogamma should be discontinued by gradually reducing the dose over a two-week period.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Particularly at the beginning of treatment, dry mouth, headache, feeling of weakness and dizziness have been reported very commonly. These symptoms often decrease after the first few weeks of treatment.

Very common (may occur in more than 1 user in 10):

Dry mouth.
Common (may occur with up to 1 in 10 users per 100):

Headache, dizziness, vertigo, somnolence, blood vessel enlargement, diarrhea, nausea, vomiting, digestive problems, constipation and other gastrointestinal complaints, allergic skin reactions including rash / itching, back pain, changes in thinking, insomnia to fall asleep), a sense of weakness.
Uncommon (may occur with up to 1 in 10 users per 1000):

Unusual slow heartbeat, sedation, nervousness, syncope (short-term loss of consciousness), decreased blood pressure, orthostatic hypotension (drop in blood pressure when getting up), sensations of tingling sensation (tingling) on ​​the skin of the hands and feet, angioedema (swelling of the skin), neck pain, anxiety, dryness and itching and burning of the eyes, chest swelling in men, inability to get erections and loss of sexual attraction, fluid retention (swelling), feeling weak in the legs, on scarlet release of fluid from the body, anorexia, pain in parotid.
5. How to store Moxogamma
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
Storage conditions: Store below 30 ° C.

6. Package Contents and Additional Information
What Moxogamma contains
The active substance is: Moxonidine. One film-coated tablet contains 0.3 mg of Moxonidine.

The other ingredients are:

Tablet core: Lactose monohydrate, crospovidone, povidone K25, magnesium stearate;
Film coating: Hypromellose, titanium dioxide (E171), macrogol 400, red iron oxide (E172).
What Moxogamma looks like and contents of the pack
Moxogamma 0.3 mg film-coated tablets are available in packs of 30, 50 and 100 tablets.
Not all pack sizes may be marketed.

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