Ondalenz 4 mg 5 oral films

Trade Name:

Ondalenz 4 mg 

5 Oral Soluble Films

Composition:

Each film contains:

4 mg of Ondansetron base micronized

Inactive ingredients:

Polyvinyl alcohol, Polyethylene glycol, Rice starch, Glycerol, Hydroxypropyl methyl cellulose, Sucralose, Polyethylene glycol, Menthol pellets, Strawberry flavor, Simethicone, Carmoisine Color

Properties: 

Antiemetic and anti-nauseants, Serotonin (5-HT3) antagonists 

Ondansetron is a potent, highly selective 5-HT3 receptor-antagonist. 

Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating the vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in postoperative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting. 

Ondansetron does not alter plasma prolactin concentrations. The role of ondansetron in opiate-induced emesis is not yet established.

Indications:

Adults: 

• Prophylaxis of acute nausea and vomiting induced by moderately emetogenic chemotherapy.
• Prophylaxis and treatment of delayed nausea and vomiting induced by moderately to highly emetogenic chemotherapy. 
• Prophylaxis and treatment of acute and delayed nausea and vomiting induced by highly emetogenic radiotherapy. •Prophylaxis and treatment of postoperative nausea and vomiting (PONV). 

Pediatric Population: 

• Management of chemotherapy-induced nausea and vomiting in children aged 26 months. 
• Prophylaxis and treatment of postoperative nausea and vomiting (PONV) in children aged 24 years. 

Dosage and administration:

-Ondalenz is only indicated for oral use. Please refer to the relevant SmPC for other dosage forms of ondansetron. -Ondalenz may be recommended in patients with an enhanced risk of aspiration. It can be useful for patients that experience difficulties in swallowing, e.g., children or the elderly. 

Method of administration: 

The oral soluble film should be taken orally. It should be placed on the tongue where it dissolves rapidly. 

Do not handle the oral soluble film with wet hands! 

1. a) Take the pouch, locate the arrow mark at one of the shorter sides and hold the pouch with this side facing up. 
2. b) Gently peel both parts of the pouch apart at the arrow mark. Now you can hold each between your thumb and your index finger using one hand for each part
3. c) Carefully tear both parts of the pouch into opposite directions until they are separated. The Oral soluble film is now visible and placed on one of the separated pouch parts. 
4. d) Take the Oral soluble film with dry fingers out of the pouch and put it in your mouth directly on your tongue. It will dissolve rapidly 

Contraindications :

-Hypersensitivity to ondansetron or to other selective 5-HT3-receptor antagonists (e.g. granisetron, dolasetron) or to any of the excipients.

-Based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphine is contraindicated. 

Warnings and precautions: •Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5HT3 receptor antagonists. Respiratory events should be treated symptomatically and clinicians should pay particular attention to them as precursors of hypersensitivity reactions. Ondansetron prolongs the QT interval in a dose-dependent manner.

• Avoid ondansetron in patients with congenital long QT syndrome. Ondansetron should be administered with caution to patients who have or may develop prolongation of QTc, including patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation or electrolyte abnormalities. 
• Hypokalemia and hypomagnesemia should be corrected prior to ondansetron administration. 
• There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs)). If concomitant treatment with ondansetron and other serotonergic drugs is clinically warranted, appropriate observation of the patient is advised. 
• As ondansetron is known to increase large bowel transit time, patients with signs of subacute intestinal obstruction should therefore be monitored following administration. 
• In patients with adeno-tonsillar surgery prevention of nausea and vomiting with ondansetron may mask occult bleeding. Therefore, such patients should be followed carefully after ondansetron administration. 

Fertility, pregnancy and lactation:

Women of childbearing potential should consider the use of contraception. 

Pregnancy:

• Based on human experience from epidemiological studies, ondansetron is suspected to cause orofacial malformations when administered during the first trimester of pregnancy. 
• The available epidemiological studies on cardiac malformations show conflicting results. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. •Ondansetron should not be used during the first trimester of pregnancy. 

Breastfeeding:

Tests have shown that Ondansetron passes into the milk of lactating animals. It is therefore recommended that mothers receiving ondansetron should not breast feed their babies.

Side effects:

• Immune system disorders:

Rare: Immediate hypersensitivity reactions sometimes severe, including anaphylaxis. 

• Nervous system disorders:

Very common: Headache. 

Uncommon: seizures, movement disorders including extrapyramidal reactions (such as dystonic reactions, oculogyric crisis and dyskinesia have been observed without definitive evidence of persistent clinical sequelae). 

Rare: Dizziness during rapid intravenous administration. 

• Eye disorders:

Rare: Transient visual disturbances (e.g. blurred vision) predominantly during intravenous administration. 

Very rare: transient blindness predominantly during intravenous administration. 

• Cardiac disorders:

Uncommon: Arrhythmias, chest pain with or without ST segment, depression, bradycardia. 

Rare: QTc prolongation, vascular disorders 

Common: Sensation of warmth or flushing. 

Uncommon: Hypotension. 

• Respiratory, thoracic and mediastinal disorders:

Uncommon: Hiccups. 

• Gastrointestinal disorders:

Common: Constipation 

• Hepatobiliary disorders:

Uncommon: Asymptomatic increases in liver function tests. These events were observed commonly in patients receiving chemotherapy with cisplatin. 

• Skin and subcutaneous tissue disorders 

Very rare: Toxic skin eruption, including toxic epidermal necrolysis 

Storage:

Store at a temperature not exceeding 30°C, in a dry place.

Keep the pouch tightly closed in order to protect from moisture.

Package:

5 oral soluble films packed in individual sealed child resistant pouches , each pouch in a four – layer pouch from outside to inside (paper, polyethylene LDPE, aluminum, polyethylene LDPE) and insert leaflet.