Amfetamin Actavis Side effects

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What are the possible side effects of Amfetamin Actavis?

Amfetamin Actavis can cause serious side effects, including:

  • See Important information for information on reported heart and mental problems.
  • slowing of growth (height and weight) in children

Common side effects of amphetamine products include:

  • dry mouth
  • decreased appetite
  • weight loss
  • stomach pain
  • nausea
  • trouble sleeping
  • restlessness
  • extreme mood changes
  • dizziness
  • increased heart rate

Talk to your doctor if you or your child have any side effects that bother you or do not go away.

These are not all the possible side effects of Amfetamin Actavis. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Amfetamin Actavis in details

infoA side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Drug Dependence
  • Hypersensitivity to amphetamine, or other components of Amfetamin Actavis
  • Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors
  • Serious Cardiovascular Reactions
  • Blood Pressure and Heart Rate Increases
  • Psychiatric Adverse Reactions
  • Long-Term Suppression of Growth
  • Peripheral Vasculopathy, including Raynaud's phenomenon

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trials Experience with Other Amphetamine Products in Pediatric Patients and Adults with ADHD

Cardiovascular: Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System: Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea.

Eye Disorders: Vision blurred, mydriasis.

Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.

Endocrine: Impotence, changes in libido.

Skin: Alopecia.

Clinical Trials Experience with Amfetamin Actavis in Pediatric Patients with ADHD

There is limited experience with Amfetamin Actavis in controlled trials. Based on this limited experience, the adverse reaction profile of Amfetamin Actavis appears similar to other amphetamine extended-release products. The most common (≥2% in the Amfetamin Actavis group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6–12 years) were: epistaxis, allergic rhinitis and upper abdominal pain.

Table 1. Common adverse reactions occurring in ≥2% of Subjects on Amfetamin Actavis and greater than Placebo during the double blind phase.
Preferred Term Amfetamin Actavis

(N=52)

Placebo

(N=48)

Respiratory, thoracic and mediastinal disorders
Epistaxis 3.8% 0%
Rhinitis allergic 3.8% 0%
Gastrointestinal disorders
Abdominal pain upper 3.8% 2.1%

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of other amphetamine products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Endocrine: frequent or prolonged erections.

Musculoskeletal, Connective Tissue, and Bone Disorders: rhabdomyolysis.

Psychiatric Disorders: dermatillomania.

What is the most important information I should know about Amfetamin Actavis?

  • Tell your doctor or dentist that you take Amfetamin Actavis before you receive any medical or dental care, emergency care, or surgery.
  • Amfetamin Actavis may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Amfetamin Actavis with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or other serious heart problem, talk with your doctor about other therapies to treat your condition.
  • Amfetamin Actavis may cause sleeplessness. Do not take Amfetamin Actavis near your bedtime unless your doctor tells you otherwise.
  • Amfetamin Actavis may cause circulation problems in the hands and feet. Tell your doctor if you have any numbness, pain, tingling, cold feeling, or skin color change (eg, from pale to blue or red) in your hands or feet. Call your doctor right away if you have any unexplained sores or wounds on your fingers or toes.
  • Amfetamin Actavis may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Amfetamin Actavis.
  • You may need to have some heart tests before starting Amfetamin Actavis. Discuss any questions or concerns with your doctor.
  • Check your blood pressure and heart rate as your doctor has told you. Discuss any questions or concerns with your doctor.
  • Lab tests may be performed while you use Amfetamin Actavis. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Amfetamin Actavis should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
  • Amfetamin Actavis may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Amfetamin Actavis.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amfetamin Actavis while you are pregnant. Amfetamin Actavis is found in breast milk. Do not breast-feed while taking Amfetamin Actavis.

When used for long periods of time or at high doses, Amfetamin Actavis may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Amfetamin Actavis stops working well. Do not take more than prescribed.

Some people who use Amfetamin Actavis for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Amfetamin Actavis, you may experience WITHDRAWAL symptoms. These may include severe fatigue and drowsiness.

Amfetamin Actavis contraindications

infoContraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Amfetamin Actavis is contraindicated:

  • In patients known to be hypersensitive to amphetamine, or other components of Amfetamin Actavis. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products.
  • During treatment with MAOIs, and also within 14 days following discontinuation of treatment with a MAOI, because of the risk of hypertensive crisis.

Reviews

The results of a survey conducted on ndrugs.com for Amfetamin Actavis are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Amfetamin Actavis. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

Consumer reported side effects

No survey data has been collected yet


Consumer reviews

Berché30 Jan 2015 09:28
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