5 mg, 10 mg tablets 
buspirone hydrochloride

1. What Anksilon is and what it is used for

Anksilon is a drug used to treat the symptoms of anxiety disorders of clinically significant severity. The main symptoms are anxiety, worry, and tension. Buspirone hydrochloride contained in Anksilon may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before taking Anksilon

Do not take Anksilon

  • if you are allergic to buspirone hydrochloride or any of the other ingredients of this medicine (listed in section 6)
  • if you have acute narrow-angle glaucoma (eye disease)
  • if you have myasthenia gravis (severe muscle weakness)
  • if you have any severe liver or kidney disease
  • if you have epilepsy
  • if you have acute alcohol, sleeping pills, pain medication, or psychosis medication poisoning.

Warnings and cautions

Talk to your doctor or pharmacist before taking Anksilon

– if you have been taking any sedatives for a long time. Before using Anksilon, these medicines should be discontinued gradually

– if you have had any kidney or liver disease

– if you have had seizures

– if you have been addicted to drugs.

Children and young people

Anksilon must not be used by children and adolescents under 18 years of age (see “How to take Anksilon” below).

Other medicines and Anksilon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is especially important that you tell your doctor if you are taking any of the following medicines:

– Drugs called monoamine oxidase inhibitors ( MAOIs ), e.g. phenelzine or tranylcypromine (for depression and Parkinson’s disease ). You should not use these medicines at the same time as Anksilon.

– Drugs called selective serotonin reuptake inhibitors ( SSRIs ), such as fluoxetine, fluvoxamine, and paroxetine (for depression and other mental disorders).

– Blood pressure medications

– Diabetes drugs

– Anticoagulant drugs, e.g. warfarin (to prevent blood clots)

– Contraceptives

– Cardiac glycosides, i.a. digoxin (for heart failure )

– Antihistamines (for allergies and hypersensitivity)

– Dexamethasone (for inflammatory and autoimmune conditions, eg rheumatoid arthritis )

– Phenytoin, phenobarbital, carbamazepine (for epilepsy )

– Nefazodone (for depression)

– Erythromycin ( antibiotic for various bacterial infections)

Linezolid (for severe infections caused by gram-positive bacteria)

– Itraconazole (against fungal infections)

– Diltiazem or verapamil (for high blood pressure, angina pectoris, heart failure and to prevent migraine attacks)

– Triptans (for migraines )

– Tramadol (for severe pain)

– Cimetidine (for heartburn and stomach ulcers )

– Rifampicin (for tuberculosis and other infections )

– Strong CYP3A4 inhibitors (eg ketoconazole and ritonavir)

– Baclofen (against spasticity)

– Lofexidine (for opiate withdrawal)

– Nation (for nausea and vomiting)

– Haloperidol (for schizophrenia, acute psychotic conditions, and delirium )

– Trazodone (for depression)

– Lithium (against bipolar disorder )

– St. John’s wort (for depression)

– L-tryptophan (nutritional supplement)

– Diazepam (for anxiety, sleep disorders, seizures (including epileptic seizures), muscle spasms, restless legs syndrome, alcohol withdrawal, benzodiazepine withdrawal, and Ménière’s disease )

Your doctor may need to consider a dose adjustment.

Anksilon with food, drink, and alcohol

Alcohol

Do not drink alcohol while taking Anksilon.

Grapefruit juice

Do not drink or eat products that contain large amounts of grapefruit juice when taking Anksilon.

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.

Pregnancy

Anksilon should not be used during pregnancy.

Breast-feeding

Breastfeeding is not recommended during treatment with Anksilon.

Driving ability and use of machines

Do not drive or use any tools or machines until you know how Anksilon affects you. It is not inconceivable that Anksilon affects your ability to react, especially at the beginning of treatment and after dose changes.

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

Anksilon contains lactose

The product contains lactose. One 5 mg tablet contains 59.5 mg of lactose and one 10 mg tablet 118.9 mg. 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 use Anksilon

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

Adults (over 18 years)

The recommended starting dose is 5 mg three times daily (equivalent to 15 mg buspirone hydrochloride daily).

The doctor may, if necessary, increase the dose gradually. The daily dose can be increased to 20-30 mg of buspirone hydrochloride, which is divided into several doses during the day. A single dose of buspirone hydrochloride must not exceed 30 mg and the daily dose of buspirone hydrochloride must not exceed 60 mg.

Patients with kidney and/or liver problems

These patients may need a lower dose. The doctor will adjust the dose individually for you.

Use for children and adolescents

Anksilon must not be used by children and adolescents under 18 years of age.

Method of administration

The tablets have a score line and can be divided into two equal doses. The tablets or tablet halves must not be chewed or crushed but must be swallowed whole with a suitable liquid. The tablets should always be taken at the same time of day, either always on an empty stomach or always after a meal.

Length of treatment

It may take some time before you start to feel better. If your symptoms do not improve within 4-8 weeks, talk to your doctor. Your doctor will decide how long you should continue to take Anksilon. If long-term treatment is needed, the doctor should follow up with the treatment carefully and review the need for continued treatment at regular intervals.

Take the medicine pack with you.

Typical symptoms of overdose include nausea, vomiting, dizziness, fatigue, small pupils, and abdominal pain.

If you forget to take Anksilon

Do not take a double dose to make up for a forgotten dose. If you miss a dose, take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as before.

If you stop taking Anksilon

Keep taking Anksilon until your doctor tells you to stop. If you need long-term treatment, your doctor will monitor your use of the medicine at regular intervals.

If you stop taking Anksilon, follow your doctor’s instructions carefully. This is especially important given that this type of medicine must not be stopped suddenly.

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.

Stop taking Anksilon and contact a doctor immediately if you get any of the following:

Rare side effects are ( may affect up to 1 in 1000 users )

– Serotonin syndrome (fever, confusion, agitation, sweating, tremors, tremors, hallucinations (strange visions or sounds), sudden muscle twitching, or palpitations).

– Allergic reaction ( itching, difficulty breathing, or swelling of the face, lips, throat, tongue, or skin).

The following side effects have also been reported:

Common side effects are (may affect up to 1 in 10):

– non-specific chest pain

– nightmares, drowsiness, insomnia, dizziness, nervousness, dizziness, impaired concentration, anxiety, anger, hostility, confusion, depression

– dimsyn

– earrings

– sore throat, nasal congestion

– nausea, dry mouth, gastrointestinal symptoms, diarrhea

– headache, weakness

Less common side effects are (may affect up to 1 in 100):

– short periods of fainting, low or high blood pressure, very fast pulse / arrhythmia

– weakening of personality consciousness, hypersensitivity to certain sound frequency ranges, elation, unpleasant mood (with symptoms such as melancholy, irritation, anxiety), compulsive movements, anxiety, despair, associative disorders, hallucinations, suicidal thoughts, seizures

numbness, abnormal sensations (including tingling and stinging sensation),

coordination disorders, involuntary tremors

– significant increase in respiratory rate, shortness of breath, pressure over the chest, altered sense of smell

red eyes, itchy eyes, inflammation of the outer layer of the eye and the inner surface of the eyelids

– increased appetite, loss of appetite, drooling, rectal bleeding, constipation, flatulence, irritable bowel syndrome, vomiting

symptoms of the lower urinary tract

– swelling, hives, hot flashes, tendency to get bruises, hair loss, dry skin, eczema, blisters, swollen face

– muscle cramps, muscle pain, muscle tension, joint pain

– weight gain, fever, headaches, weight loss, general malaise, fatigue, altered taste, sweating, cold sweaty hands

elevated liver values

– menstrual disorders, increased or decreased sexual desire

Rare side effects are (may affect up to 1 in 1000):

– circulatory disorder in the brain, heart failure, heartbeat, dysfunction of the heart muscle, slow resting heart rate

altered blood counts (increase in certain white blood cells [eosinophilia], decrease in certain blood cell types [leukopenia], decrease in platelet count [thrombocytopenia])

– mood swings, claustrophobia, cold intolerance, drowsiness that can lead to reduced mobility or unconsciousness, slurred speech, psychosis, transient memory gaps

– extrapyramidal symptoms, i.a. involuntary body movements during or after treatment, involuntary movements in the body, face, mouth, or tongue and stiffness in the body, parkinsonism (with symptoms such as slow movements and shaking), akathisia (with symptoms such as restlessness, inability to sit still), restless legs syndrome (with symptoms such as burning, itching or tingling sensation in the leg muscles), slow reactivity

– eye pain, photosensitivity, pressure in the eyes, the limited circular tunnel-like field of vision

– nosebleeds

– involuntary urination, need to urinate at night

– small skin hemorrhages, acne, thin nails

– muscle weakness

– milk secretion from the breasts, breast enlargement in men, disorders of thyroid function

– alcohol abuse, bleeding, loss of voice, hiccups, burning sensation in the tongue

– missed menstruation, pelvic inflammatory disease, ejaculation disorder, impotence

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. How to store Anksilon

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/blister after EXP. The expiry date will be the last day of that month.

No special temperature instructions.

Blister:

Store the blister in the outer carton. Sensitive to light.

HDPE tablet jar:

Use within 1 year after first opening.

The medicine 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 buspirone hydrochloride.- 5 mg: One tablet contains 5 mg buspirone hydrochloride.- 10 mg: One tablet contains 10 mg buspirone hydrochloride. The other ingredients are lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate.

What the medicine looks like and the contents of the pack

5 mg:

Anksilon 5 mg tablets are white or almost white, oval tablets marked “ORN 30” on one side and a breaker on the other side.

The tablet can be divided into two equal parts.

10 mg:

Anksilon 10 mg tablets are white or almost white, oval tablets marked “ORN 31” on one side and a breaker on the other side.

The tablet can be divided into two equal parts.

Pack sizes:

Blisters: 20, 30, 50, 60, 90 and 100 tablets.

Jar: 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Hold a marketing authorization

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation

Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation

Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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