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Active Ingredients:Isotretinoin

In addition to the beneficial effects of ORATANE®it is possible that unwanted effects will occur during treatment, even when it is used as directed.

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking ORATANE®Capsules.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • dryness of the lips, mouth, nose, eyes and skin. Soften these areas not affected by Acne with moisturiser or petroleum jelly to avoid dryness
  • fragile skin
  • change in colour of the skin
  • peeling of skin on palms of hands and soles of feet
  • itchy skin rash
  • an increased susceptibility to sunburn
  • sweating
  • changes to nails
  • eye problems such as dry, sore, swollen or itchy eyes, discharge or trouble seeing at night
  • nosebleeds
  • tenderness, stiffness in bones, joints or muscles
  • headache
  • tiredness
  • temporary hair loss (sometimes occurs and is usually temporary but in rare cases has persisted)
  • excessive hairiness
  • hoarseness

These side effects are usually mild and dose related. After the dose of ORATANE®Capsules is reduced or stopped most these side effects should disappear within a few days or weeks.

Stop taking ORATANE®Capsules and contact your doctor immediately if you experience any of the following:

  • vomiting
  • nausea
  • persistent headache
  • blurred vision or visual disturbances
  • changes in your hearing or ringing in your ears
  • severe upper stomach pain
  • blood in stools or severe diarrhoea
  • severe skin rash or severe bruising
  • thinking, seeing or hearing things that are not real
  • feeling depressed with or without suicidal thoughts

Symptoms of depression may include:

  • start to feel sad or have crying spells
  • lose interest in activities you once enjoyed
  • sleep too much or have trouble sleeping
  • become more irritable, angry or aggressive than usual e.g. temper outbursts, thoughts of violence
  • have a change in your appetite or body weight
  • have trouble concentrating
  • withdraw from your friends or family
  • feel like you have no energy
  • have feelings of worthlessness or inappropriate guilt
  • start having thoughts about hurting yourself or taking your own life (suicidal thoughts).

These may be serious side effects and may require urgent medical attention. Serious side effects are rare.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some unknown side effects.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.In some cases your doctor may want to reduce your dose or stop treatment.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

If you are concerned about these or any other unexpected effects, please talk to your doctor.

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