5 mg, 10 mg, 15 mg, 20 mg orodispersible tablets 
olanzapine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Arkolamyl is and what it is used for 
2. What you need to know before you take Arkolamyl 
3. How to take Arkolamyl 
4. Possible side effects 
5. How to store Arkolamyl 6. Contents of the pack 
and other ingredients information 

1. What Arkolamyl is and what it is used for

Arkolamyl contains the active substance olanzapine. Olanzapine belongs to the group of drugs neuroleptics and is used to treat the following mental health conditions:

  • Schizophrenia, a condition with symptoms such as hearing, seeing or sensing something that does not exist, delusions, unusual suspicion, and withdrawal. People with these conditions may also feel depressed, anxious, or tense.
  • Moderate to severe manic episodes, a condition with symptoms such as arousal and euphoria.

Arkolamyl prevents the recurrence of these symptoms in patients with bipolar disorder where treatment with the drug has had an effect in the manic phase.

Olanzapine contained in Arkolamyl may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Arkolamyl

Do not take Arkolamyl

  • if you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can manifest itself as a rash, itching, swollen face, swelling of the lips, tongue, or throat, difficulty breathing, or shortness of breath. If this happens, consult your doctor.
  • if you have previously had eye problems such as certain types of glaucoma(increased pressure in the eye).

Warnings and cautions

Talk to your doctor or pharmacist before taking Arkolamyl if:

  • You are elderly and have dementia because you can get serious side effects.
  • you or someone in your family has had a blood clot in the past, as drugs like this have been linked to blood clots.
  • you have had a stroke or mild form of stroke (temporary symptoms of stroke )
  • you have Parkinson’s disease because your symptoms may worsen
  • you have an enlarged prostate
  • you have intestinal upset (paralytic ileus )
  • you have problems with your liver or kidneys
  • you have problems with your blood cells
  • you have a heart condition
  • you have abnormal heart activity (seen on ECG )
  • you have low levels of potassium or magnesium in your blood
  • you have diabetes
  • you have or have had seizures or seizures ( epilepsy )
  • you are a smoker

During treatment

If you experience a combination of very high fever, shortness of breath, heavy sweating, mood swings, muscle stiffness, high blood pressure, and drowsiness or drowsiness, contact your doctor. He/she may decide to discontinue treatment with Arkolamyl.

If you experience uncontrollable movements in the face or tongue, contact your doctor. He/she may reduce the dose or decide to discontinue Arkolamyl.

Weight gain has occurred in patients taking olanzapine. You and your doctor should check your weight regularly. Consider referral to a dietitian or help with a diet list if necessary.

Your doctor may also want to take blood samples before you start taking Arkolamyl and regularly during treatment to check your blood sugar and fat levels.

If you are over 65 years of age, your blood pressure should be checked regularly by your doctor.

Children and young people

Arkolamyl is not recommended for patients under 18 years of age.

Other medicines and Arkolamyl

Only take other medicines during Arkolamyl treatment if your doctor advises you to do so.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. In particular any of the following:

  • antidepressants and sleeping pills (sedatives) because you may feel drowsy.
  • medicines for Parkinson’s disease.
  • carbamazepine ( antiepileptic and mood stabilizer).
  • fluvoxamine (antidepressant).
  • ciprofloxacin ( antibiotic ).
  • activated carbon. You should take this at least two hours before or after taking Arkolamyl.

Arkolamyl with alcohol

Do not drink alcohol during treatment with Arkolamyl, as Arkolamyl together with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will discuss with you if you should take this medicine while you are pregnant.

You should not take this medicine if you are breast-feeding, as small amounts of Arkolamyl may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used Arkolamyl during the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, anxiety, difficulty breathing, and difficulty eating. If your child has any of these symptoms, you may need to consult a doctor.

Driving and using machines

There is a risk that you may feel drowsy or dizzy when using Arkolamyl. If this happens, do not drive or use any tools or machines and consult your doctor.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.

Arkolamyl 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.

3. How to take Arkolamyl

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one and the duration of treatment is determined by your doctor. The recommended dose of Arkolamyl is 5-20 mg per day. Contact your doctor if the symptoms return but do not stop taking the medicine unless your doctor tells you to.

You should take Arkolamyl orodispersible tablets once a day according to your doctor’s prescription. Try to take Arkolamyl at the same time each day either at mealtime or between meals.

Arkolamyl orodispersible tablets break easily and should therefore be handled with care. The tablets may break if you take them with damp hands.

  1. Hold the tablet map by the edge and loosen a “box” by gently tearing along the perforation.
  2. Carefully pull off the foil.
  3. Gently push up the tablet.
  4. Put the tablet in your mouth, it dissolves immediately and can then be easily swallowed.

You can also put the tablet in a glass of water, orange juice, apple juice, milk, or in a cup of coffee and stir. Depending on the drink, the mixture may change color and possibly become cloudy. Drink up immediately.

How to use Arkolamyl

Patients who have taken too much Arkolamyl have the following symptoms: rapid heart rate, agitation/aggression, speech difficulties, involuntary movement disorders (especially in the face or tongue), and loss of consciousness. Other symptoms may include acute confusion, seizures ( epilepsy ), coma, a combination of fever, shortness of breath, sweating, muscle stiffness, and drowsiness or drowsiness, slow breathing, inhalation of fluid in the trachea and lungs, often after being ill (aspiration), difficulty breathing, high or low blood pressure, abnormal heart rhythm.

If you forget to use Arkolamyl

Take your tablets as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking Arkolamyl

It is important that you follow your doctor’s instructions and do not stop taking the medicine because you feel better.

If you suddenly stop taking Arkolamyl, you may experience symptoms such as sweating, difficulty sleeping, tremors, anxiety or nausea, and vomiting. Your doctor may recommend that you reduce the dose gradually before stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor or see the nearest emergency department immediately if you get the following side effects:

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

  • Increased number of infections that cause fever, severe chills, sore throat, or cold sores (this may be a sign that you have a low number of white blood cells )

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

  • involuntary movements especially in the face, tongue, cheeks, or jaws, which can later also occur in the arms and legs ( tardive dyskinesia ).
  • irregular heartbeat
  • blood clots in the veins especially in the legs (symptoms are swelling, pain, and redness on the legs). Blood clots can be transported to the lungs and cause chest pain and difficulty breathing.
  • allergic reactions such as rash, itching or swelling of the face, lips, tongue, or throat, difficulty breathing, or shortness of breath.
  • diabetes or exacerbation of diabetes, sometimes associated with ketoacidosis(ketones in the blood or urine) or coma
  • difficulty urinating or emptying the bladder
  • seizures in general with known susceptibility to seizures ( epilepsy )

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

  • A combination of very high fever, faster breathing, heavy sweating, mood swings, muscle stiffness, high blood pressure, and drowsiness or drowsiness
  • chills, cold or pale skin (these may be signs that your body temperature is lower than normal)
  • very fast heartbeats that can be harmful
  • severe abdominal pain that may radiate to the back (this may be a sign of pancreatic problems)
  • yellowing of the skin or whites of the eyes, dark urine, pale stools, fatigue, fever, nausea, weakness, drowsiness, and abdominal pain (these may be signs of liver problems)
  • muscle breakdown that causes muscle pain, weakness, or soreness along with dark urine ( rhabdomyolysis )

Has been reported (occurs in an unknown number of users):

  • flu-like symptoms with rash on the face and then more widespread rash, fever, enlarged lymph nodes, elevated levels of liver enzymes seen in blood tests, and elevated levels of a type of white blood cell ( eosinophils ). This may be a sign of a drug reaction with eosinophilia and systemic symptoms (DRESS).

Other side effects include:

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

  • weight gain
  • somnolence
  • increased levels of prolactin in the blood that can be measured in blood tests
  • At the beginning of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This often disappears by itself. If this is not the case then contact your doctor

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

  • changes in levels of white blood cells, blood fats, and temporary increase in liver enzymes early in treatment that can be measured in blood samples
  • increased blood sugar and urine levels, which can be measured in blood or urine samples
  • increase in the levels of uric acid and creatine phosphatase in the blood, which can be measured in blood samples
  • increased appetite
  • dizziness
  • restlessness
  • tremors, stiff posture, slow movements, and a sluggish, unsteady gait ( Parkinsonism )
  • involuntary movements ( dyskinesia )
  • constipation
  • dry mouth
  • rash
  • abnormal weakness
  • extreme fatigue
  • fluid retention leading to swelling of the hands, ankles, or feet
  • decreased sex drive in men and women or problems getting or maintaining an erection in men.
  • fever
  • joint pain

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

  • uncontrollable muscle stiffness or spasm that affects the head (including eye movements), neck, or body
  • an ant crawls and feeling of restless legs at rest (restless legs)
  • speech problems
  • stuttering
  • slow heart rate
  • increased sun sensitivity in the skin
  • nosebleeds
  • bloated feeling in the stomach
  • dreglande
  • memory loss or forgetfulness
  • inability to control urination, difficulty urinating or maintaining urine flow
  • hair loss
  • missed or shortened menstruation.
  • increased breast size in men or women
  • abnormal production of breast milk in women.
  • an increased amount of bilirubin in the blood measured in blood samples

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

  • sudden, unexplained death
  • signs of withdrawal symptoms such as sweating, difficulty sleeping, tremors, anxiety, nausea or vomiting
  • unexplained bruising and increased tendency to bleed or bleed longer than usual
  • prolonged and/or painful erection.

When taking olanzapine, elderly patients with dementia may experience a stroke, pneumonia, urinary incontinence, increased tendency to fall, extreme fatigue, visual hallucinations, increased body temperature, reddening of the skin, and difficulty walking. Some deaths have been reported in this specific patient group.

For patients with Parkinson’s disease, Arkolamyl may make the symptoms worse.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Arkolamyl

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 carton or blister after “EXP”. The expiration date is the last day of the specified month.

Store in the original package. Sensitive to light. Moisture sensitive.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is olanzapine. Each Arkolamyl orodispersible tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of the active substance.
  • The other ingredients are crospovidone, lactose monohydrate (see section 2, Arkolamyl contains lactose ), anhydrous colloidal silica, hydroxypropyl cellulose, mint flavor (consisting of mint oil, turpentine-free mint oil, eucalyptol, menthone, someone, menthyl acetate), methyl acetate;

What the medicine looks like and the contents of the pack

Arkolamyl 5 mg orodispersible tablet is yellow, round, and biconvex

Arkolamyl 10 mg, an orodispersible tablet is yellow, round, and smooth

Arkolamyl 15 mg orodispersible tablet is yellow, round, and biconvex

Arkolamyl 20 mg, an orodispersible tablet is yellow, round, and smooth

Mouthwash tablet is a term for a tablet that dissolves directly in the mouth so that it can be easily swallowed.

Blister:

Arkolamyl 5 mg, 10 mg, 15 mg and 20 mg are supplied in packs of 10, 28, 30, 56, 60, 70, 84, 90, 98, 100, 112 orodispersible tablets.

Endosblister:

Arkolamyl 5 mg, 10 mg, 15 mg, and 20 mg are supplied in packs of 28 x 1 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Mylan AB

Box 23033

104 35 Stockholm

Manufacturer:

Pharmathen SA Dervenakion 6, 15351 Pallini, Attiki, Greece

and

McDermott Laboratories Limited. t / a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Muhammad Nadeem

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