5 mg, 10 mg tablets 
buspirone hydrochloride

What Buspiron Actavis is and what it is used for

Buspirone Actavis affects a neurotransmitter ( serotonin ) in the brain, which causes anxiety and tension to subside.

Buspirone Actavis is used for long-term treatment of anxiety, worry and restlessness without panic attacks. Anxiety can be primary but also due to another illness or alcohol dependence.

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

What you need to know before you use Buspiron Actavis

Do not use Buspiron Actavis

  • If you are allergic to buspirone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
  • If you have severe liver or kidney function.
  • If you have epilepsy .
  • In case of acute poisoning of alcohol, sleeping pills, painkillers or antipsychotic drugs.

Warnings and cautions

Talk to your doctor or pharmacist before using Buspiron Actavis.

Buspirone Actavis should be used with caution:

  • with concomitant use of drugs that have an effect on the central nervous system
  • if you have narrow-angle glaucoma ( glaucoma )
  • if you have myasthenia gravis muscle disease
  • if you have impaired liver or kidney function
  • if you have a drug addiction
  • if you have had seizures in the past.

Although Buspiron Actavis has not been shown to potentiate the effects of alcohol, the basic rule should be not to use alcohol with medicines.

Children and young people

Buspiron Actavis is not recommended for children and adolescents under 18 years of age.

Other medicines and Buspiron Actavis

The treatment effect may be affected if Buspiron Actavis is taken with certain other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This especially applies to concomitant treatment with:

  • MAO inhibitors (drugs for Parkinson’s disease and depression)
  • selective serotonin reuptake inhibitors ( SSRIs, eg fluvoxamine), nefazodone, L-tryptophan, and trazodone (antidepressants).
  • Lithium (remedy for manic-depressive illness).
  • Triptans (anti-migraine drugs ).
  • Tramadol (painkiller).
  • Haloperidol ( antidepressant ).
  • Carbamazepine, phenobarbital, phenytoin (antiepileptic drugs ).
  • Erythromycin, itraconazole, rifampicin, linezolid (anti- infective ).
  • Diltiazem , verapamil, digoxin (means for high blood pressure or heart disease).
  • Cimetidine (remedy for heartburn and acid reflux).
  • Baclofen (muscle relaxant).
  • Lefoxidine (drug for heroin and opiate dependence).
  • Nabilon (anti-nausea and vomiting).
  • Antihistamines are (anti-allergy drugs ).
  • Diazepam (anxiolytic, muscle relaxant and sedative).

Also tell your doctor if you are using herbal remedies, such as St. John’s wort .

Buspiron Actavis with food and drink

Grapefruit juice increases the concentration of buspirone in the blood. Therefore, if you are taking Buspiron Actavis, you should avoid drinking large amounts of grapefruit juice.

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 for advice before using this medicine.

Limited experience of use during pregnancy.

It is unknown whether Buspiron Actavis passes into breast milk.

Driving and using machines

Buspiron Actavis has a moderate effect on the ability to drive and use machines. Risks that have been noticed are that you become drowsy and dizzy from this medicine.

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.

Buspirone Actavis contains excipients

Buspirone Actavis contains lactose

Buspirone Actavis contains lactose monohydrate . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Buspirone Actavis contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Buspiron Actavis

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

The recommended dose is 1 tablet of 10 mg twice daily or 1 tablet of 5 mg 3 times daily during the first week of treatment. Thereafter, the dose is increased gradually to 20-30 mg per day, divided into 2-3 dosing times, as evenly distributed as possible during the day. Dose one should not exceed 20 mg at each dosing occasion. The maximum daily dose is 60 mg.

Buspirone Actavis should be taken at the same time each day.

You should take the tablets in the same way, with or without food, each time.

The effect of the medication is usually obtained within 2-3 weeks.

If you forget to use Buspiron Actavis

Do not take a double dose to make up for a forgotten tablet.

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.

If side effects of Buspiron Actavis occur, they usually occur at the beginning of treatment and are usually transient.

Stop taking Buspiron Actavis and contact a doctor immediately or see your nearest emergency department if you experience the following symptoms:

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

  • angioedema (symptoms may include swelling of the tongue, throat and respiratory tract with difficulty breathing).

Very rare (may affect up to 1 in 10,000 people): 

  • serotonergic syndrome (symptoms may include severe agitation, tension, sweating, coordination problems and fever).

Other side effects that may occur: 

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

  • dizziness, headache and drowsiness.

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

  • nervousness, difficulty falling asleep, impaired concentration, confusion and sleep disorders
  • anger, depression
  • palpitations, chest pain
  • nausea, abdominal pain, diarrhea, constipation and vomiting
  • dry mouth
  • rash
  • muscle and skeletal pain
  • “Ant crawls”, difficulty coordinating movements, tremors
  • dimsyn
  • ringing sound in the ears
  • nasal congestion, sore throat
  • cold sweats and weakness.

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

  • Hypersensitivity reaction with rash.

Very rare (may affect up to 1 in 10,000 people): 

  • difficulty / inability to sit still, tremors in hands, abnormal muscle tension, stiffness, involuntary movements, movement difficulties and parkinsonism
  • feeling of loss of identity, emotional fluctuations, hallucinations, psychosis , seizures, transient memory disorder
  • fainting
  • tunnel vision
  • spasmodic and prolonged erection
  • difficulty urinating
  • excretion of breast milk
  • restlessness.

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 Buspiron Actavis

Store in the original package.

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 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is buspirone hydrochloride. One tablet contains 5 mg and 10 mg buspirone hydrochloride respectively.
  • The other ingredients are: lactose monohydrate 59.7 mg (5 mg tablet) and 119.4 mg (10 mg tablet), microcrystalline cellulose, sodium starch glycolate, colloidalanhydrous silica and magnesium stearate.

What the medicine looks like and contents of the pack

Appearance

5 mg tablet: White, round, flat, marked ‘CCL’.

10 mg tablet: White, round, flat, scored, marked ‘CCD’.

Pack sizes

Blister pack: 30, 100, 50 x 1 (single dose pack) tablets.

Plastic jar: 250 tablets (for dose dispensing only).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjordur

Iceland

Local representative

Manufacturer

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str,

Dupnitsa 2600

Bulgaria

Muhammad Nadeem

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