Read through this prospectus carefully before taking this pharmaceutical drug. Keep this prospectus, you may need to reread it. If you have any doubts or questions, consult your physician or pharmacist. This pharmaceutical drug has been prescribed for you personally and you should not pass it on to others. It may prove harmful to them, even though their symptoms may be the same as your own.

IN THIS PROSPECTUS

1. What Prozac 20-mg hard capsules are and what they are used for
2. Before taking Prozac 20-mg hard capsules
3. How to take Prozac 20-mg hard capsules
4. Possible side effects
5. Storing Prozac 20-mg hard capsules

Each hard capsule contains 20 mg of fluoxetine as its main ingredient. The other ingredients (excipients) are: corn starch and dimeticone. The ingredients of the gelatin capsule are: gelatin, blue food coloring (E131), yellow iron oxide (E172) and titanium oxide (E171).

1. What Prozac 20mg hard capsules are and what they are used for.

Prozac 20-mg hard capsules come in the form of opaque yellow and opaque green capsules. Each box contains blisters of 14 or 28 capsules. Prozac belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). Prozac is recommended for the treatment of:

• Depression
• Obsessive-compulsive disorders
• Bulimia nervosa

2. Before taking Prozac 20mg hard capsules.

Do not take Prozac

• If you have ever had (or believe to have had) a rash or allergic reaction to fluoxextine or to any of the ingredients in this drug. Allergy may be accompanied by rash, itchiness, swelling of the face or lips, or shortness of breath.
• If you are taking (or have taken at some point during the past two weeks) any drug known as a monoamine oxidase inhibitor (also known as MAOI). In this case, Prozac treatment can begin:
• Two weeks after ending treatment with an irreversible MAO inhibitor
• The day after ending treatment with a reversible MAO inhibitor.
• If you are taking PROZAC and need to change your treatment to a MAOI, wait at least five weeks between discontinuing Prozac medication and administering any MAOI.

Be especially careful with Prozac

• If you suffer from or have suffered in the past from convulsions.
• If you suffer from or have suffered in the past from some type of hemorrhage.
• If you have ever received electroconvulsive therapy (ECT).
• If you are suffering or have suffered any of the following diseases, report it to your physician as soon as possible:
• Diabetes
• Heart disease
• Liver or kidney disease
• History of mania (physical or mental hyperactivity) / hypomania
• Weight loss may take place during Prozac treatment.
• With depression, suicide attempts must not be ruled out. This tendency may persist until a significant recovery has taken place.

The following may appear during Prozac treatment

• Skin rash
• Allergic reactions
• Serotonin syndrome characterized by a number of symptoms, such as fever, stiff joints, muscle shaking, dizziness when getting up, excessive perspiration, irregular heartbeat, confusion, irritability or extreme agitation.
• Consult your physician if any one of these symptoms has occurred to you at any time.

Pregnancy
Consult your physician or pharmacist before taking any drug. Prozac should only be used during pregnancy when your physician believes that the expected therapeutic benefits will justify it. Special caution is required, above all during the final stage of pregnancy and just before childbirth.
Breast-feeding
Consult your physician or pharmacist before taking any drug. Because Prozac is excreted into mother's milk, do not breast-feed during treatment with this drug.
Driving and operating machinery
Given that Prozac may cause drowsiness, lower reflexes and alter your capacity to react, try not to carry out tasks that might require special attention (driving or operating machinery) until you know how this drug affects you.
Taking other pharmaceutical drugs
Inform your physician or pharmacist if you are taking or have recently taken other pharmaceutical drugs, including those sold over the counter. Certain drugs may interact with Prozac. In these cases it may be necessary to change the dosage or discontinue treatment of one of these.
Inform your physician if you are taking or have recently taken any of the following drugs:

• Antidepressants known as monoamine oxidase inhibitors (MAOI) (See "Do not take Prozac").
• Drugs that affect blood coagulation, such as: oral anticoagulants, non-steroid anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, typical antipsychotic drugs such as clozapine, phenothiazines or tricyclic antidepressants.
• Parapharmaceutical medicines or medicinal plant preparations containing St John's Wort (Hypericum perforatum).
• Phenytoin (for the treatment of epilepsy).
• Tramadol (for the treatment of pain).
• Triptans (for the treatment of migraine).
• Lithium or tryptophan (for the treatment of depression.
• Flecainide and encainide (for the treatment of heart arrhythmias).
• Carbamazepine (for the treatment of epilepsy).
• Tricyclic antidepressants.
• Avoid alcoholic drinks during Prozac treatment.

Bear in mind that these instructions may be applied to drugs you have taken or used before taking Prozac.

3. How to take Prozac

Follow these directions unless your physician has instructed you otherwise.
Remember to take your medicine.
Your physician will inform you as to the length of your Prozac treatment.
Do not stop treatment until you are told to do so.
Prozac dosage will vary depending on the illness that has been diagnosed.

Depression: the recommended initial dosage is 20 mg.
Bulimia nervosa: the recommended dosage is 60 mg daily.
Obsessive-compulsive disorder: the recommended dosage is 20 to 60 mg daily.
For any of the above: do not exceed 80 mg per day.
Even though several weeks may go by before you feel better, do not neglect to take your treatment, and follow your physician’s instructions carefully. Do not stop the treatment, even if you feel better, without consulting your physician.
Effects that may take place when Prozac treatment is discontinued: When you stop your Prozac treatment, you may experience the following symptoms:
Dizziness, a tingling sensation, headache, anxiety and nausea. The majority of these are moderate and temporary.
If you take more Prozac than you should: If you take more Prozac than you should, consult your physician or pharmacist at once. Overdose symptoms include nausea, vomiting, convulsions, cardiovascular problems, and signs of alteration of the CNS (Central Nervous System) from restlessness to coma. In the case of overdose or accidental swallowing, consult your doctor or local toxicological office.
If you missed taking Prozac: Take your capsule as soon as you remember. Do not take a double dose to compensate for the missed dose(s).

4. Possible Side Effects

Like all drugs, Prozac may have side effects.
The following side effects have been seen in association with Prozac:
General reactions: Allergic reactions such as prickling, skin rash, hives, inflamed blood vessels, serum sickness, swollen tissue, shivering, a hot feeling, flushing, palpitations (serotonin syndrome), sensitivity to daylight, very rare cases of skin peeling (toxic epidermal necrolysis or Lyell syndrome).
Digestive system: gastrointestinal disorders (e.g. diarrhea, nausea, vomiting, poor digestion, difficulty swallowing, alteration in the sense of taste), dry mouth. Rare cases have been reported of hepatic anomalies. Very rare cases of hepatitis.
Nervous system: Headache, sleep disorders (e.g. abnormal dreams, insomnia), dizziness, anorexia, fatigue (e.g. drowsiness, sleepiness), euphoria, transitory abnormal movements (e.g. muscle spasms, instability, trembling, muscle shakes, convulsions and psychomotor agitation. Hallucinations, manic reactions, confusion, agitation, anxiety and associated symptoms (e.g. nervousness), difficulty concentrating and thinking (e.g. depersonalization), panic attacks (these symptoms may be due to the underlying mental disorder).
Respiratory system: Pharyngitis, difficulty breathing. Rare cases have been reported of pulmonary alternations.
Urogenital system: Sexual dysfunction (delayed ejaculation or impotence, inability to reach orgasm), prolonged and/or painful erection, milk secretion.
Other side effects: Hair loss, yawning, abnormal vision (e.g. dilation of the pupils), perspiration, vasodilation, pain in the joints, muscular pain, low blood pressure when getting up (hypotension), swollen eyelids. Rare cases have been reported of hemorrhages (e.g. vaginal hemorrhages, gastrointestinal hemorrhages and other skin or musosal hemorrhages. Low sodium levels in the blood (hyponatremia).
Symptoms resulting from conclusion of the treatment such as: dizziness, a tingling sensation, headache, anxiety and nausea.
If you notice any unpleasant side effect not mentioned in this prospectus, report it to your physician or pharmacist.

5. Storing Prozac

Keep Prozac out of children's reach and sight.
The expiry date for this medicine is printed on the label. Do not use this medicine after this date.